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Innovasis, Inc.

33 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) (K251073)Innovasis, Inc.2025-07-23
Innovasis Navigation Instruments (K250182)Innovasis, Inc.2025-03-24
Vector™ Pedicle Screw System (K241276)Innovasis, Inc.2024-05-20
HAtetracell™-C Titanium Cervical IBF System (K231899)Innovasis, Inc.2023-10-17
Excella Navigation Instruments (K223511)Innovasis, Inc.2023-05-02
Matrix HA Fusion Porous Cervical IBF System (K223510)Innovasis, Inc.2022-12-12
HAcancellous PEEK-C Porous HA PEEK Cervical IBF System (K220875)Innovasis, Inc.2022-08-26
AxTiHA Stand-Alone ALIF System (K212967)Innovasis, Inc.2021-10-15
TxTiHA IBF System, AxTiHA Stand-Alone ALIF System (K201614)Innovasis, Inc.2020-07-15
TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End (K200874)Innovasis, Inc.2020-06-30
Oryx Cervical Plate System (K192049)Innovasis, Inc.2019-11-08
Innovasis Gibralt Spine System (K192354)Innovasis, Inc.2019-09-24
TxTi IBF System (K183064)Innovasis, Inc.2019-06-28
AXTi Titanium Stand-Alone ALIF System (K182139)Innovasis, Inc.2019-06-21
LxHA PEEK Lateral IBF System (K190684)Innovasis, Inc.2019-06-17
CxHA PEEK Cervical IBF System (K181115)Innovasis, Inc.2018-07-16
Kestrel™ Buttress Plate System (K181063)Innovasis, Inc.2018-07-13
Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System (K180078)Innovasis, Inc.2018-04-17
Ax Stand-Alone ALIF System (K162236)Innovasis, Inc.2017-04-20
FixxSure® X-Link (K162143)Innovasis, Inc.2016-09-23
Px HA PEEK IBF System (K151785)Innovasis, Inc.2015-10-14
Px PEEK IBF System (K150500)Innovasis, Inc.2015-06-19
INNOVASIS CRANIAL SYSTEM (K141644)Innovasis, Inc.2014-11-07
PFX SPINOUS PROCESS FIXATION SYSTEM (K132765)Innovasis, Inc.2014-07-14
EXCELLA III-D SPINAL DEFORMITY SYSTEM (K140238)Innovasis, Inc.2014-05-07
C-BOX PEEK CERVICAL IBF (K132991)Innovasis, Inc.2014-02-12
BOX PEEK VBR SYSTEM, (K121581)Innovasis, Inc.2012-10-17
EXCELLA II SPINAL SYSTEM MODEL EC2-00 (K102248)Innovasis, Inc.2010-10-07
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS) (K071921)Innovasis, Inc.2007-11-16
BOX PEEK VBR SYSTEM (K062151)Innovasis, Inc.2006-12-22
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM (K061147)Innovasis, Inc.2006-06-30
EXCELLA-M SPINAL SYSTEM (K042143)Innovasis, Inc.2004-10-07
PEEK CEMENT RESTRICTOR X-BOX (K041583)Innovasis, Inc.2004-07-22

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Every clearance here is in the API, with alerts when new ones post.