Medical Device Manufacturer · US , Gainesville , FL

Exactech, Inc.

185 submissions · 173 cleared · Since 1986
185
Total
173
Cleared
0
Denied

Exactech, Inc. — FDA 510(k) Submissions

Exactech, Inc. has submitted 185 FDA 510(k) premarket notifications since 1986, of which 173 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Shoulder Prosthesis, Reverse Configuration, Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented . Use the specialty filter in the sidebar to narrow results.

185 devices
1–25 of 185
Equinoxe? Humeral Reconstruction Prosthesis; Equinoxe? Stemless Shoulder Implants
K250713 · KWT Prosthesis, Shoulder,... · Orthopedic
Dec 2025 266d
Equinoxe? Shoulder System
K243448 · PHX Shoulder Prosthesis,... · Orthopedic
Aug 2025 267d
Equinoxe? Scapula Fracture System
K243275 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2025 253d
Alteon? HA Femoral Stems
K243839 · MEH Prosthesis, Hip,... · Orthopedic
Mar 2025 87d
Exactech? TRULIANT? Knee System
K240393 · MBH Prosthesis, Knee,... · Orthopedic
Oct 2024 238d
Equinoxe? Central Screw Baseplate System
K233482 · PHX Shoulder Prosthesis,... · Orthopedic
Jul 2024 266d
Exactech? Vantage? Total Ankle System
K230717 · HSN Prosthesis, Ankle,... · Orthopedic
Oct 2023 211d
Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws
K223933 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2023 269d
Exactech? Equinoxe? Reverse Humeral Liners and Humeral Adapter Trays
K223833 · PHX Shoulder Prosthesis,... · Orthopedic
Sep 2023 266d
Vantage? Total Ankle System
K232002 · HSN Prosthesis, Ankle,... · Orthopedic
Sep 2023 68d
TRULIANT? E-PX Tibial Inserts; TRULIANT? E-PX Patellas
K223252 · JWH Prosthesis, Knee,... · Orthopedic
Jul 2023 269d
Exactech? Alteon? Short Tapered Wedge
K221323 · LZO Prosthesis, Hip,... · Orthopedic
May 2023 378d
Exactech? Equinoxe? Laser Cage Glenoid
K212356 · KWS Prosthesis, Shoulder,... · Orthopedic
Mar 2022 218d
Exactech? Equinoxe? Stemless Humeral Components
K192097 · PKC Prosthesis, Total... · Orthopedic
Apr 2020 268d
Exactech? Equinoxe? Reverse Shoulder Glenospheres
K193098 · PHX Shoulder Prosthesis,... · Orthopedic
Feb 2020 105d
Exactech Alteon Modular Dual Mobility (MDM) System
K190890 · LZO Prosthesis, Hip,... · Orthopedic
Oct 2019 200d
Exactech Equinoxe Humeral Augmented Trays
K191561 · PHX Shoulder Prosthesis,... · Orthopedic
Aug 2019 68d
Vantage Total Ankle Flat Cut Talar Components
K183343 · HSN Prosthesis, Ankle,... · Orthopedic
Apr 2019 119d
Alteon Acetabular Cup System
K182502 · LPH Prosthesis, Hip,... · Orthopedic
Mar 2019 182d
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
K182346 · MBH Prosthesis, Knee,... · Orthopedic
Nov 2018 90d
Exactech Alteon Highly Polished Femoral Stem
K182462 · LZO Prosthesis, Hip,... · Orthopedic
Nov 2018 59d
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 · PHX Shoulder Prosthesis,... · Orthopedic
Oct 2018 28d
Truliant Porous Femoral Components
K181794 · MBH Prosthesis, Knee,... · Orthopedic
Sep 2018 85d
Exactech Alteon Monobloc Revision Stem
K181532 · LZO Prosthesis, Hip,... · Orthopedic
Sep 2018 85d
Exactech Equinoxe Small Reverse Shoulder System
K180632 · PHX Shoulder Prosthesis,... · Orthopedic
Jul 2018 135d

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