Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

187 results for "Exactech, Inc."
25–48 of 187
Search insights Median review: 86d Cleared: 100% Top manufacturer: Exactech, Inc. Lead specialty: Orthopedic
Cleared Sep 04, 2018
Exactech Alteon Monobloc Revision Stem
K181532 · LZO
Exactech, Inc.
Orthopedic · 85d
Cleared Jul 25, 2018
Exactech Equinoxe Small Reverse Shoulder System
K180632 · PHX
Exactech, Inc.
Orthopedic · 135d
Cleared Mar 12, 2018
Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
K173583 · OQI
Exactech, Inc.
Orthopedic · 112d
Cleared Mar 09, 2018
Exactech Equinoxe Stemless Shoulder
K173388 · PKC
Exactech, Inc.
Orthopedic · 130d
Cleared Jun 08, 2017
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
K170821 · NKB
Choicespine, LP
Orthopedic · 80d
Cleared Apr 28, 2017
Exactech® Truliant™ Line Extensions
K171045 · JWH
Exactech, Inc.
Orthopedic · 21d
Cleared Apr 26, 2017
Exactech® Alteon® HA Femoral Stem
K162732 · MEH
Exactech, Inc.
Orthopedic · 209d
Cleared Mar 06, 2017
Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse...
K162325 · PHX
Exactech, Inc.
Orthopedic · 199d
Cleared Feb 27, 2017
Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
K162903 · KWT
Exactech, Inc.
Orthopedic · 133d
Cleared Feb 23, 2017
Truliant Femoral Components
K170240 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 01, 2017
Exactech® Equinoxe® Preserve Stem
K162726 · PHX
Exactech, Inc.
Orthopedic · 125d
Cleared Aug 31, 2016
Exactech® Novation® Element Press-fit Femoral Stem
K153649 · MEH
Exactech, Inc.
Orthopedic · 254d
Cleared Jun 28, 2016
Gibralt® Spine System and Gibralt® Occipital Spine System
K160697 · NKG
Exactech, Inc.
Orthopedic · 106d
Cleared Mar 25, 2016
Optetrak Logic Metaphyseal Cones
K153595 · JWH
Exactech, Inc.
Orthopedic · 100d
Cleared Mar 18, 2016
Optetrak Advanced Patella
K160484 · JWH
Exactech, Inc.
Orthopedic · 25d
Cleared Mar 10, 2016
Optetrak One Logic Femoral Components
K153776 · MBH
Exactech, Inc.
Orthopedic · 70d
Cleared Mar 10, 2016
Exactech Vantage Total Ankle System
K152217 · HSN
Exactech, Inc.
Orthopedic · 216d
Cleared Sep 03, 2015
Exactech Optetrak Logic Enhanced Assembly
K152170 · JWH
Exactech, Inc.
Orthopedic · 30d
Cleared Sep 03, 2015
Exactech® Novation® Crown Cup®
K141960 · LPH
Exactech, Inc.
Orthopedic · 412d
Cleared Jul 20, 2015
Exactech Alteon Monobloc Revision Stem
K150066 · LZO
Exactech, Inc.
Orthopedic · 188d
Cleared May 29, 2015
Exactech Optetrak Logic CC
K150890 · JWH
Exactech, Inc.
Orthopedic · 57d
Cleared May 28, 2015
Ascendant TM Cervical Spacer System
K150130 · ODP
Exactech, Inc.
Orthopedic · 127d
Cleared May 14, 2015
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
K150458 · PHX
Exactech, Inc.
Orthopedic · 80d
Cleared May 11, 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · MAX
Exactech, Inc.
Orthopedic · 108d