Atlas FDA

JEC

85 FDA 510(k) clearances · Product code

64 daysmedian time to decision
232 days90th percentile
85clearances measured

FDA profile

Official device name
Component, Traction, Invasive
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2010: 13 · 2011: 15 · 2012: 14 · 2013: 10 · 2017: 12 · 2023: 26
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SteriTrak (K203605)Arbutus Medical, Inc.2021-04-23
Anjon Bremer Halo System (K193256)Anjon Holdings, LLC2020-03-02
DigiFix Sterile Kit (K192465)Virak Orthopedics, LLC2019-10-10
PIP Fix (K181192)Hand Biomechanics Lab, Inc.2018-10-22
Anjon Bremer Halo System (K171863)Anjon Holdings, LLC2018-03-19
Medline ReNewal Reprocessed Stryker External Fixation Devices (K163028)Surgical Instrument Service and Savings, Inc.2016-12-28
DIGIFIX EXTERNAL FIXATION SYSTEM (K132731)Virak Orthopedic Research, LLC2014-01-10
HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX (K102885)Stryker Corp.2011-01-14
LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (K082679)Sintea Biotech, Inc.2009-04-07
F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE (K072432)Hand Biomechanics Lab, Inc.2008-01-09
SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP (K071476)Synthes (Usa)2007-08-24
KLSA MARTIN HAND DISTRACTOR (K042066)KLS-Martin L.P.2004-08-25
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM (K032427)Meridan Medical2003-10-09
HOFFMANN II COMPACT BALTIMORE COUPLING (K031941)Howmedica Osteonics Corp.2003-07-24
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS (K030519)Hand Biomechanics Lab, Inc.2003-06-10
ORTHOGUARD AB ANTIMICROBIAL SLEEVE (K022676)Smith & Nephew, Inc.2002-09-23
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X (K022065)Sintea Biotech, Inc.2002-08-06
AMC ANTIMICROBIAL PIN/WIRE SLEEVE (K012193)Smith & Nephew, Inc.2002-07-11
AUTOGENESIS AUTOMATOR, MODEL M1000 (K013818)Autogenesis, Inc.2001-12-05
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST (K003848)Howmedica Osteonics Corp.2001-01-11
BREMER HALO SYSTEM TITANIUM SKULL PIN (K993099)Depuyacromed1999-12-15
CENTRAFIX EXTERNAL FIXATOR (K991732)Owandar Medical, Ltd.1999-05-21
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147 (K984442)Hand Biomechanics Lab, Inc.1999-02-12
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 (K981423)Autogenesis, Inc.1998-05-20
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM (K971755)Howmedica Corp.1997-07-17
STABLELOC II EXTERNAL FIXATOR (K965029)Acu Med, Inc.1997-02-19
MONOTUBE CARBON TUBE (K963614)Howmedica Corp.1996-11-06
HOFFMANN II CARBON CONNECTING ROD (K961916)Howmedica, Inc.1996-08-01
MONOTUBE TUBE TO RING CLAMP (K961618)Howmedica Corp.1996-05-28
TITANIUM TUBE TO TUBE CLAMP (K960782)Synthes (Usa)1996-05-08
EZ FIX (K954838)Biodynamic Technologies, Inc.1996-01-24
MONOTUBE TUBE-TO-TUBE CLAMP (K954667)Howmedica Corp.1996-01-11
EXTERNAL FIXATOR (K952330)Acu Med, Inc.1995-10-05
HOFFMANN II EXTERNAL FIXATION SYSTEM (K952730)Howmedica Corp.1995-09-08
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM (K944092)Orthofix Srl1995-04-04
EXTERNAL FIXATOR (K943857)Acu Med, Inc.1995-01-27
ACE PELVIC STABILIZER (K933968)Ace Medical Co.1994-06-16
PELVIC C-CLAMP (K922796)Synthes (Usa)1994-03-10
HOWMEDICA MONOTUBE T-CONNECTOR (K936124)Howmedica, Inc.1994-02-22
TEXAS SCOTTISH RITE EASY/LOCK FIXATOR (K931578)Applied Osteo Systems, Inc.1994-02-22
ACE UNILATERAL FIXATOR II (K936045)Ace Orthopedic Manufacturing Co.1994-02-22
HOWMEDICA MONO-TUBE SINGLE PIN CLAMP (K934698)Howmedica Corp.1994-02-22
SYSTEM III HALO RING (K930153)Jerome Medical1993-08-06
HALO ESPRIT (K920117)Itm Corp.1992-10-06
OSTEO EX-FI-RE (K920149)Osteo AG1992-04-09
BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN (K915800)Bremer Medical, Inc.1992-03-16
ACE OPEN-BACK HALO RING (K914858)Ace Medical Co.1991-11-21
CYPRESS CERVICAL TRACTION EQUIPMENT, CYPRESS HALO (K894959)Alphatec Mfg., Inc.1990-09-14
OLIVE K-WIRES (K903105)Danek Medical, Inc.1990-09-06
ACE WIRE TENSION CLAMP (K901984)Buckman Co., Inc.1990-06-21
SYNTHES EXTERNAL FIXATION BONE CLIP (K894098)Synthes (Usa)1990-04-30
ACE WIRE TENSION CLAMP (K894982)Buckman Co., Inc.1990-01-11
TRACER DYNAMIC AXIAL FIXATION (K892638)Tracer Medical1989-08-11
AME PINSITE SHIELD(TM) (K884798)American Medical Electronics, Inc.1989-02-10
MODIFIED CHICK AMBULATORY HALO (K884242)Chick Medical Products1988-12-29
JMS CERVICAL TRACTION DEVICE/HALO DEVICE (K882877)Jerome Medical1988-09-30
KIRSCHNER SUPER-FIXATION SYSTEM (K881896)Kirschner Medical Corp.1988-07-28
LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER (K881673)Lima-Lto, Inc.1988-06-03
LIMA-LTO. SEM MODULAR EXTERNAL STABLIZER (K880282)Lima-Lto, Inc.1988-02-18
VITAPATCH PIN PROTECTION DEVICE FOR PERCUT. PINS (K872538)Vitaphore Corp.1987-07-10
EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129) (K852397)Howmedica Corp.1985-08-09
AGEE EXTERNAL FIXATOR (K842493)The Hand Biomechanics Research Laboratory1985-02-13
SABA-COOMBS MINI EXTERNAL FIXATOR (K842343)Zimmer, Inc.1984-09-11
RICHARDS FIXATOR SYSTEM (K841334)Richards Medical Co., Inc.1984-05-16
MODULAR CONSTRUCT FRAME EXTERNAL FIXA (K840856)Precision Medical Devices, Inc.1984-04-25
OXFORD MARK 2 EXTERNAL FIXATOR (K833114)Johnson & Johnson Professionals, Inc.1983-10-20
ORTHOFIX (K831576)Electro-Biology, Inc.1983-06-08
COLLES FRACTURE FRAME (K830154)Richard'S Medical Equip., Inc.1983-02-02
CERVICAL BRACE (K822780)Jerome Medical1982-10-06
DOUBLE BALL JOINT (K803166)Howmedica Corp.1981-01-09
ORTHOFIX AXIALEXTERNAL FIXATION SYS. (K802814)Cintor Orthopaedic Div.1980-12-10
EXTENDED BALLJOINT GRIP (K802723)Howmedica Corp.1980-11-19
HOFFMAN LEG LENGTHENING DEVICE (K802776)Howmedica Corp.1980-11-19
EXTERNAL FIXATION SYSTEM (K802722)Howmedica Corp.1980-11-19
OXFORD EXTERNAL FIXATION SYSTEM (K800184)Downs Surgical , Ltd.1980-02-11
MINI-H-FIXATION (K792561)Geny Medical, Inc.1979-12-19
ACE EXTERNAL BONE CLAMP PART #S11 (K791466)Ace Orthopedic Manufacturing Co.1979-08-16
UNIVERSAL EXTERNAL FIXATION ASSEMBLY (K790262)Zimmer, Inc.1979-02-13
EXTERNAL ARTICULATION (K781840)Ace Orthopedic Manufacturing Co.1978-11-08
BONE CLAMP, ACE EXTERNAL (K781839)Ace Orthopedic Manufacturing Co.1978-11-08
BAR, DISTRACTION (K781841)Ace Orthopedic Manufacturing Co.1978-11-08
FRAME, UNIVERSAL DAY (K781793)B.G. Orthopedic Corp.1978-11-03
TIBIAL COMPRESSION FRAM FOR FRACTURES (K770066)Richard F. Kronner, M.D.1977-03-30
FRACTURE REDUCTION SYS., MODEL OR 1001 (K770388)Sisan Assoc.1977-03-14
DEPUY MODIFIED SKELETAL TRACTION PIN (K761088)Depuy, Inc.1976-12-17

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