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."
1–24 of 187
Search insights Median review: 86d Cleared: 100% Top manufacturer: Exactech, Inc. Lead specialty: Orthopedic
Cleared Apr 14, 2026
Equinoxe® Shoulder System
K260583 · PHX
Exactech, Inc.
Orthopedic · 53d
Cleared Dec 01, 2025
Equinoxe® Humeral Reconstruction Prosthesis
K250713 · KWT
Exactech, Inc.
Orthopedic · 266d
Cleared Aug 01, 2025
Equinoxe® Shoulder System
K243448 · PHX
Exactech, Inc.
Orthopedic · 267d
Cleared Jun 26, 2025
Equinoxe® Scapula Fracture System
K243275 · HRS
Exactech, Inc.
Orthopedic · 253d
Cleared Mar 10, 2025
Alteon® HA Femoral Stems
K243839 · MEH
Exactech, Inc.
Orthopedic · 87d
Cleared Oct 03, 2024
Exactech® TRULIANT® Knee System
K240393 · MBH
Exactech, Inc.
Orthopedic · 238d
Cleared Jul 18, 2024
Equinoxe® Central Screw Baseplate System
K233482 · PHX
Exactech, Inc.
Orthopedic · 266d
Cleared Oct 12, 2023
Exactech® Vantage® Total Ankle System
K230717 · HSN
Exactech, Inc.
Orthopedic · 211d
Cleared Sep 25, 2023
Exactech Equinoxe PHx Fracture System
K223933 · HRS
Exactech, Inc.
Orthopedic · 269d
Cleared Sep 14, 2023
Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays
K223833 · PHX
Exactech, Inc.
Orthopedic · 266d
Cleared Sep 11, 2023
Vantage® Total Ankle System
K232002 · HSN
Exactech, Inc.
Orthopedic · 68d
Cleared Jul 17, 2023
TRULIANT® E-PX Tibial Inserts
K223252 · JWH
Exactech, Inc.
Orthopedic · 269d
Cleared May 19, 2023
Exactech® Alteon® Short Tapered Wedge
K221323 · LZO
Exactech, Inc.
Orthopedic · 378d
Cleared Mar 04, 2022
Exactech® Equinoxe® Laser Cage Glenoid
K212356 · KWS
Exactech, Inc.
Orthopedic · 218d
Cleared Apr 29, 2020
Exactech® Equinoxe® Stemless Humeral Components
K192097 · PKC
Exactech, Inc.
Orthopedic · 268d
Cleared Feb 20, 2020
Exactech® Equinoxe® Reverse Shoulder Glenospheres
K193098 · PHX
Exactech, Inc.
Orthopedic · 105d
Cleared Oct 22, 2019
Exactech Alteon Modular Dual Mobility (MDM) System
K190890 · LZO
Exactech, Inc.
Orthopedic · 200d
Cleared Aug 20, 2019
Exactech Equinoxe Humeral Augmented Trays
K191561 · PHX
Exactech, Inc.
Orthopedic · 68d
Cleared Apr 01, 2019
Vantage Total Ankle Flat Cut Talar Components
K183343 · HSN
Exactech, Inc.
Orthopedic · 119d
Cleared Mar 13, 2019
Alteon Acetabular Cup System
K182502 · LPH
Exactech, Inc.
Orthopedic · 182d
Cleared Nov 26, 2018
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
K182346 · MBH
Exactech, Inc.
Orthopedic · 90d
Cleared Nov 08, 2018
Exactech Alteon Highly Polished Femoral Stem
K182462 · LZO
Exactech, Inc.
Orthopedic · 59d
Cleared Oct 12, 2018
Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe...
K182536 · PHX
Exactech, Inc.
Orthopedic · 28d
Cleared Sep 28, 2018
Truliant Porous Femoral Components
K181794 · MBH
Exactech, Inc.
Orthopedic · 85d