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."
145–168 of 187
Search insights Median review: 86d Cleared: 100% Top manufacturer: Exactech, Inc. Lead specialty: Orthopedic
Cleared Aug 29, 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493 · JDI
Exactech, Inc.
Orthopedic · 26d
Cleared Jul 31, 2001
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
K012251 · JWH
Exactech, Inc.
Orthopedic · 13d
Cleared Jul 16, 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976 · JWH
Exactech, Inc.
Orthopedic · 21d
Cleared May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · JDI
Exactech, Inc.
Orthopedic · 26d
Cleared Apr 24, 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
K011081 · LPH
Exactech, Inc.
Orthopedic · 14d
Cleared Mar 13, 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
K010434 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 09, 2001
MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH...
K010120 · LPH
Exactech, Inc.
Orthopedic · 24d
Cleared Feb 08, 2001
CEMEX SYSTEM GUN APPLICATION VERSION
K000943 · LOD
Exactech, Inc.
Orthopedic · 322d
Cleared Feb 05, 2001
ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS
K010081 · KWY
Exactech, Inc.
Orthopedic · 26d
Cleared Aug 16, 2000
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH...
K002141 · LWJ
Exactech, Inc.
Orthopedic · 30d
Cleared May 18, 2000
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
K001335 · JDI
Exactech, Inc.
Orthopedic · 21d
Cleared Feb 16, 2000
ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES...
K000242 · MEH
Exactech, Inc.
Orthopedic · 20d
Cleared Jan 20, 2000
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT
K993736 · LPH
Exactech, Inc.
Orthopedic · 77d
Cleared Nov 19, 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR...
K993082 · LPH
Exactech, Inc.
Orthopedic · 65d
Cleared Feb 04, 1999
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
K990197 · MEH
Exactech, Inc.
Orthopedic · 15d
Cleared Dec 27, 1996
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
K964262 · JDI
Exactech, Inc.
Orthopedic · 63d
Cleared Nov 14, 1996
EXACTECH ALL POLY ACETABULAR CUP
K963313 · JDI
Exactech, Inc.
Orthopedic · 84d
Cleared Oct 01, 1996
AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM
K961304 · JDI
Exactech, Inc.
Orthopedic · 180d
Cleared Aug 08, 1996
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
K962002 · JDG
Exactech, Inc.
Orthopedic · 78d
Cleared Apr 23, 1996
EXACTECH STERILE MODULAR DRILL BIT
K960720 · HWE
Exactech, Inc.
Orthopedic · 61d
Cleared Mar 27, 1996
OPTEON UNIPOLAR
K960538 · KWL
Exactech, Inc.
Orthopedic · 49d
Cleared Feb 26, 1996
OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
K954208 · JWH
Exactech, Inc.
Orthopedic · 172d
Cleared Mar 10, 1995
EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
K933494 · JWH
Exactech, Inc.
Orthopedic · 599d
Cleared Feb 09, 1995
EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY
K932690 · JWH
Exactech, Inc.
Orthopedic · 616d