Exactech, Inc. - FDA 510(k) Cleared Devices
185
Total
173
Cleared
0
Denied
184 devices
Cleared
Mar 12, 2018
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
Orthopedic
112d
Cleared
Mar 09, 2018
Exactech Equinoxe Stemless Shoulder
Orthopedic
130d
Cleared
Apr 28, 2017
Exactech® Truliant™ Line Extensions
Orthopedic
21d
Cleared
Apr 26, 2017
Exactech® Alteon® HA Femoral Stem
Orthopedic
209d
Cleared
Mar 06, 2017
Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse...
Orthopedic
199d
Cleared
Feb 27, 2017
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
Orthopedic
133d
Cleared
Feb 23, 2017
Truliant Femoral Components
Orthopedic
28d
Cleared
Feb 01, 2017
Exactech® Equinoxe® Preserve Stem
Orthopedic
125d
Cleared
Aug 31, 2016
Exactech® Novation® Element Press-fit Femoral Stem
Orthopedic
254d
Cleared
Jun 28, 2016
Gibralt® Spine System and Gibralt® Occipital Spine System
Orthopedic
106d
Cleared
Mar 25, 2016
Optetrak Logic Metaphyseal Cones
Orthopedic
100d
Cleared
Mar 18, 2016
Optetrak Advanced Patella
Orthopedic
25d
Cleared
Mar 10, 2016
Exactech Vantage Total Ankle System
Orthopedic
216d
Cleared
Mar 10, 2016
Optetrak One Logic Femoral Components
Orthopedic
70d
Cleared
Sep 03, 2015
Exactech® Novation® Crown Cup®
Orthopedic
412d
Cleared
Sep 03, 2015
Exactech Optetrak Logic Enhanced Assembly
Orthopedic
30d
Cleared
Jul 20, 2015
Exactech Alteon Monobloc Revision Stem
Orthopedic
188d
Cleared
May 29, 2015
Exactech Optetrak Logic CC
Orthopedic
57d
Cleared
May 28, 2015
Ascendant TM Cervical Spacer System
Orthopedic
127d
Cleared
May 14, 2015
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
Orthopedic
80d
Cleared
May 11, 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
Orthopedic
108d
Cleared
Apr 09, 2015
Equinoxe Mega Prosthesis
Orthopedic
107d
Cleared
Feb 27, 2015
Exactech Ambassador
Orthopedic
72d
Cleared
Aug 28, 2014
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7
Orthopedic
52d
Cleared
Aug 15, 2014
EXACTECH CERVICAL SPACER SYSTEM
Orthopedic
106d
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