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."
97–120 of 187
Search insights Median review: 86d Cleared: 100% Top manufacturer: Exactech, Inc. Lead specialty: Orthopedic
Cleared Jan 11, 2010
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES...
K093360 · JWH
Exactech, Inc.
Orthopedic · 75d
Cleared Jan 07, 2010
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM
K092900 · PHX
Exactech, Inc.
Orthopedic · 108d
Cleared Apr 21, 2009
NOVATION CFS PRESS-FIT AND CEMENTED STEMS
K090764 · LWJ
Exactech, Inc.
Orthopedic · 29d
Cleared Dec 17, 2008
NOVATION 12/14 CEMENTED FEMORAL STEMS
K083392 · LZO
Exactech, Inc.
Orthopedic · 30d
Cleared Oct 10, 2008
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
K082702 · PHX
Exactech, Inc.
Orthopedic · 24d
Cleared Sep 02, 2008
OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
K082022 · JWH
Exactech, Inc.
Orthopedic · 48d
Cleared May 06, 2008
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS
K080980 · MEH
Exactech, Inc.
Orthopedic · 29d
Cleared Feb 29, 2008
EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW
K073688 · PHX
Exactech, Inc.
Orthopedic · 63d
Cleared Aug 15, 2007
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
K071738 · JWH
Exactech, Inc.
Orthopedic · 50d
Cleared Jul 19, 2007
EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS
K071676 · KWZ
Exactech, Inc.
Orthopedic · 30d
Cleared Jun 07, 2007
OPTECURE
K063685 · MBP
Exactech, Inc.
Orthopedic · 177d
Cleared Mar 15, 2007
EXACTECH NOVATION CROWN CUP AND LINERS
K070479 · LZO
Exactech, Inc.
Orthopedic · 23d
Cleared Feb 23, 2007
EQUINOXE REVERSE SHOULDER SYSTEM
K063569 · PHX
Exactech, Inc.
Orthopedic · 86d
Cleared Nov 29, 2006
NOVATION SPLINED RDD FEMORAL STEMS
K063279 · LZO
Exactech, Inc.
Orthopedic · 29d
Cleared Sep 12, 2006
OPTECURE +CCC
K061668 · MBP
Exactech, Inc.
Orthopedic · 90d
Cleared Jun 12, 2006
EXACTECH EQUINOXE SHOULDER STEMS
K061454 · HSD
Exactech, Inc.
Orthopedic · 18d
Cleared Feb 08, 2006
OPTECURE
K050806 · MBP
Exactech, Inc.
Orthopedic · 315d
Cleared Feb 06, 2006
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K060107 · LZO
Exactech, Inc.
Orthopedic · 24d
Cleared Dec 27, 2005
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14...
K052787 · LZO
Exactech, Inc.
Orthopedic · 85d
Cleared Dec 01, 2005
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
K051858 · LZO
Exactech, Inc.
Orthopedic · 146d
Cleared Nov 18, 2005
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
K050398 · LZO
Exactech, Inc.
Orthopedic · 275d
Cleared Sep 06, 2005
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
K051556 · LPH
Exactech, Inc.
Orthopedic · 85d
Cleared Jul 19, 2005
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
K051682 · LZO
Exactech, Inc.
Orthopedic · 26d
Cleared Jun 21, 2005
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
K051335 · JDI
Exactech, Inc.
Orthopedic · 29d