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Exactech, Inc.

186 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Equinoxe® Shoulder System (K260583)Exactech, Inc.2026-04-14
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants (K250713)Exactech, Inc.2025-12-01
Equinoxe® Shoulder System (K243448)Exactech, Inc.2025-08-01
Equinoxe® Scapula Fracture System (K243275)Exactech, Inc.2025-06-26
Alteon® HA Femoral Stems (K243839)Exactech, Inc.2025-03-10
Exactech® TRULIANT® Knee System (K240393)Exactech, Inc.2024-10-03
Equinoxe® Central Screw Baseplate System (K233482)Exactech, Inc.2024-07-18
Exactech® Vantage® Total Ankle System (K230717)Exactech, Inc.2023-10-12
Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws (K223933)Exactech, Inc.2023-09-25
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays (K223833)Exactech, Inc.2023-09-14
Vantage® Total Ankle System (K232002)Exactech, Inc.2023-09-11
TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas (K223252)Exactech, Inc.2023-07-17
Exactech® Alteon® Short Tapered Wedge (K221323)Exactech, Inc.2023-05-19
Exactech® Equinoxe® Laser Cage Glenoid (K212356)Exactech, Inc.2022-03-04
Exactech® Equinoxe® Stemless Humeral Components (K192097)Exactech, Inc.2020-04-29
Exactech® Equinoxe® Reverse Shoulder Glenospheres (K193098)Exactech, Inc.2020-02-20
Exactech Alteon Modular Dual Mobility (MDM) System (K190890)Exactech, Inc.2019-10-22
Exactech Equinoxe Humeral Augmented Trays (K191561)Exactech, Inc.2019-08-20
Vantage Total Ankle Flat Cut Talar Components (K183343)Exactech, Inc.2019-04-01
Alteon Acetabular Cup System (K182502)Exactech, Inc.2019-03-13
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws (K182346)Exactech, Inc.2018-11-26
Exactech Alteon Highly Polished Femoral Stem (K182462)Exactech, Inc.2018-11-08
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap (K182536)Exactech, Inc.2018-10-12
Truliant Porous Femoral Components (K181794)Exactech, Inc.2018-09-28
Exactech Alteon Monobloc Revision Stem (K181532)Exactech, Inc.2018-09-04
Exactech Equinoxe Small Reverse Shoulder System (K180632)Exactech, Inc.2018-07-25
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners (K173583)Exactech, Inc.2018-03-12
Exactech Equinoxe Stemless Shoulder (K173388)Exactech, Inc.2018-03-09
Exactech® Truliant™ Line Extensions (K171045)Exactech, Inc.2017-04-28
Exactech® Alteon® HA Femoral Stem (K162732)Exactech, Inc.2017-04-26
Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw (K162325)Exactech, Inc.2017-03-06
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies (K162903)Exactech, Inc.2017-02-27
Truliant Femoral Components (K170240)Exactech, Inc.2017-02-23
Exactech® Equinoxe® Preserve Stem (K162726)Exactech, Inc.2017-02-01
Exactech® Novation® Element Press-fit Femoral Stem (K153649)Exactech, Inc.2016-08-31
Gibralt® Spine System and Gibralt® Occipital Spine System (K160697)Exactech, Inc.2016-06-28
Optetrak Logic Metaphyseal Cones (K153595)Exactech, Inc.2016-03-25
Optetrak Advanced Patella (K160484)Exactech, Inc.2016-03-18
Exactech Vantage Total Ankle System (K152217)Exactech, Inc.2016-03-10
Optetrak One Logic Femoral Components (K153776)Exactech, Inc.2016-03-10
Exactech® Novation® Crown Cup® (K141960)Exactech, Inc.2015-09-03
Exactech Optetrak Logic Enhanced Assembly (K152170)Exactech, Inc.2015-09-03
Exactech Alteon Monobloc Revision Stem (K150066)Exactech, Inc.2015-07-20
Exactech Optetrak Logic CC (K150890)Exactech, Inc.2015-05-29
Ascendant TM Cervical Spacer System (K150130)Exactech, Inc.2015-05-28
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere (K150458)Exactech, Inc.2015-05-14
The Octane Straight Intervertebral Fusion Device, Ti Coated (K150152)Exactech, Inc.2015-05-11
Equinoxe Mega Prosthesis (K143659)Exactech, Inc.2015-04-09
Exactech Ambassador (K143576)Exactech, Inc.2015-02-27
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET (K141821)Exactech, Inc.2014-08-28
EXACTECH CERVICAL SPACER SYSTEM (K141129)Exactech, Inc.2014-08-15
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS (K140302)Exactech, Inc.2014-07-30
ALTEON 6.5MM BONE SCREWS (K141797)Exactech, Inc.2014-07-29
EXACTECH TAPERED WEDGE FEMORAL STEM (K140674)Exactech, Inc.2014-06-30
OCTANE ELEVATE SPINAL IMPLANT SYSTEM (K123607)Exactech, Inc.2014-04-25
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM (K132582)Exactech, Inc.2014-02-12
EQUINOXE EXTRA SHORT HUMERAL HEAD (K140063)Exactech, Inc.2014-02-11
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM (K131298)Exactech, Inc.2013-11-26
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS (K132161)Exactech, Inc.2013-10-11
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT (K131575)Exactech, Inc.2013-07-03
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC (K130434)Exactech, Inc.2013-05-01
OPTETRAK LOGIC POROUS FEMORAL COMPONENT (K123687)Exactech, Inc.2013-03-20
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES (K121877)Exactech, Inc.2013-02-12
NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE (K121392)Exactech, Inc.2013-01-16
OPTETRAK LOGIC CRC TIBIAL INSERT (K123342)Exactech, Inc.2013-01-10
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE (K121067)Exactech, Inc.2012-12-06
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, (K121989)Exactech, Inc.2012-11-27
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT (K121220)Exactech, Inc.2012-11-20
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL (K122798)Exactech, Inc.2012-10-11
NOVATION LPI PRIME FEMORAL STEM (K121684)Exactech, Inc.2012-10-01
OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ (K121307)Exactech, Inc.2012-05-31
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 (K113320)Exactech, Inc.2012-03-16
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 (K113609)Exactech, Inc.2012-01-04
EXACTECH EQUINOXE CAGE GLENOIDS (K113309)Exactech, Inc.2011-12-08
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 (K112097)Exactech, Inc.2011-11-21
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC (K103699)Exactech, Inc.2011-08-12
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT (K111400)Exactech, Inc.2011-07-28
EXACTECH GIBRALT SPINAL SYSTEM (K110197)Exactech, Inc.2011-07-15
OCTANE-C INTERBODY FUSION DEVICE SYSTEM (K103655)Exactech, Inc.2011-06-30
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT (K111379)Exactech, Inc.2011-06-08
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD (K110706)Exactech, Inc.2011-05-17
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... (K110708)Exactech, Inc.2011-04-01
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM (K102870)Exactech, Inc.2011-01-21
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM (K103419)Exactech, Inc.2010-12-13
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS (K103012)Exactech, Inc.2010-11-10
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 (K102487)Exactech, Inc.2010-11-08
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE (K102975)Exactech, Inc.2010-11-05
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) (K102951)Exactech, Inc.2010-11-04
EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 (K101761)Exactech, Inc.2010-09-21
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. (K093430)Exactech, Inc.2010-09-02
OPTETRAK LOGIC COMBINATION TIBIAL TRAY (K101981)Exactech, Inc.2010-08-02
EXACTECH EQUINOXE, PLATFORM FRACTURE STEM (K101909)Exactech, Inc.2010-08-02
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER (K093275)Exactech, Inc.2010-05-27
NOVATION CROWN CUP GXL LINERS (K100269)Exactech, Inc.2010-05-27
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM (K093978)Exactech, Inc.2010-05-11
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T (K093360)Exactech, Inc.2010-01-11
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM (K092900)Exactech, Inc.2010-01-07
NOVATION CFS PRESS-FIT AND CEMENTED STEMS (K090764)Exactech, Inc.2009-04-21
NOVATION 12/14 CEMENTED FEMORAL STEMS (K083392)Exactech, Inc.2008-12-17
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY (K082702)Exactech, Inc.2008-10-10
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