Exactech, Inc.
FDA 510(k) medical device clearances.
Top product codes for Exactech, Inc.
Recent clearances by Exactech, Inc.
1–100 of 186- K260583 — Equinoxe® Shoulder System
- K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
- K243448 — Equinoxe® Shoulder System
- K243275 — Equinoxe® Scapula Fracture System
- K243839 — Alteon® HA Femoral Stems
- K240393 — Exactech® TRULIANT® Knee System
- K233482 — Equinoxe® Central Screw Baseplate System
- K230717 — Exactech® Vantage® Total Ankle System
- K223933 — Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
- K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
- K232002 — Vantage® Total Ankle System
- K223252 — TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
- K221323 — Exactech® Alteon® Short Tapered Wedge
- K212356 — Exactech® Equinoxe® Laser Cage Glenoid
- K192097 — Exactech® Equinoxe® Stemless Humeral Components
- K193098 — Exactech® Equinoxe® Reverse Shoulder Glenospheres
- K190890 — Exactech Alteon Modular Dual Mobility (MDM) System
- K191561 — Exactech Equinoxe Humeral Augmented Trays
- K183343 — Vantage Total Ankle Flat Cut Talar Components
- K182502 — Alteon Acetabular Cup System
- K182346 — TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
- K182462 — Exactech Alteon Highly Polished Femoral Stem
- K182536 — 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
- K181794 — Truliant Porous Femoral Components
- K181532 — Exactech Alteon Monobloc Revision Stem
- K180632 — Exactech Equinoxe Small Reverse Shoulder System
- K173583 — Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
- K173388 — Exactech Equinoxe Stemless Shoulder
- K171045 — Exactech® Truliant Line Extensions
- K162732 — Exactech® Alteon® HA Femoral Stem
- K162325 — Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw
- K162903 — Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
- K170240 — Truliant Femoral Components
- K162726 — Exactech® Equinoxe® Preserve Stem
- K153649 — Exactech® Novation® Element Press-fit Femoral Stem
- K160697 — Gibralt® Spine System and Gibralt® Occipital Spine System
- K153595 — Optetrak Logic Metaphyseal Cones
- K160484 — Optetrak Advanced Patella
- K152217 — Exactech Vantage Total Ankle System
- K153776 — Optetrak One Logic Femoral Components
- K141960 — Exactech® Novation® Crown Cup®
- K152170 — Exactech Optetrak Logic Enhanced Assembly
- K150066 — Exactech Alteon Monobloc Revision Stem
- K150890 — Exactech Optetrak Logic CC
- K150130 — Ascendant TM Cervical Spacer System
- K150458 — Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
- K150152 — The Octane Straight Intervertebral Fusion Device, Ti Coated
- K143659 — Equinoxe Mega Prosthesis
- K143576 — Exactech Ambassador
- K141821 — ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET
- K141129 — EXACTECH CERVICAL SPACER SYSTEM
- K140302 — OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
- K141797 — ALTEON 6.5MM BONE SCREWS
- K140674 — EXACTECH TAPERED WEDGE FEMORAL STEM
- K123607 — OCTANE ELEVATE SPINAL IMPLANT SYSTEM
- K132582 — EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
- K140063 — EQUINOXE EXTRA SHORT HUMERAL HEAD
- K131298 — EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
- K132161 — OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS
- K131575 — EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT
- K130434 — OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC
- K123687 — OPTETRAK LOGIC POROUS FEMORAL COMPONENT
- K121877 — GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES
- K121392 — NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE
- K123342 — OPTETRAK LOGIC CRC TIBIAL INSERT
- K121067 — EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE
- K121989 — OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
- K121220 — EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
- K122798 — INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
- K121684 — NOVATION LPI PRIME FEMORAL STEM
- K121307 — OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ
- K113320 — NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12
- K113609 — NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
- K113309 — EXACTECH EQUINOXE CAGE GLENOIDS
- K112097 — GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
- K103699 — EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
- K111400 — OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
- K110197 — EXACTECH GIBRALT SPINAL SYSTEM
- K103655 — OCTANE-C INTERBODY FUSION DEVICE SYSTEM
- K111379 — EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT
- K110706 — EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
- K110708 — EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
- K102870 — EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
- K103419 — EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
- K103012 — EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS
- K102487 — NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20
- K102975 — NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE
- K102951 — EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM)
- K101761 — EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13
- K093430 — EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD.
- K101909 — EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
- K101981 — OPTETRAK LOGIC COMBINATION TIBIAL TRAY
- K093275 — EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
- K100269 — NOVATION CROWN CUP GXL LINERS
- K093978 — EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
- K093360 — OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T
- K092900 — EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
- K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS
- K083392 — NOVATION 12/14 CEMENTED FEMORAL STEMS
- K082702 — EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
Data sourced from openFDA. This site is unofficial and independent of the FDA.