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."
73–96 of 187
Search insights Median review: 86d Cleared: 100% Top manufacturer: Exactech, Inc. Lead specialty: Orthopedic
Cleared Mar 16, 2012
NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA...
K113320 · MEH
Exactech, Inc.
Orthopedic · 127d
Cleared Jan 04, 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
K113609 · LPH
Exactech, Inc.
Orthopedic · 29d
Cleared Dec 08, 2011
EXACTECH EQUINOXE CAGE GLENOIDS
K113309 · KWS
Exactech, Inc.
Orthopedic · 30d
Cleared Nov 21, 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · MRW
Exactech, Inc.
Orthopedic · 122d
Cleared Aug 12, 2011
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
K103699 · NUN
Exactech, Inc.
Dental · 235d
Cleared Jul 28, 2011
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
K111400 · JWH
Exactech, Inc.
Orthopedic · 70d
Cleared Jul 15, 2011
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · MNI
Exactech, Inc.
Orthopedic · 172d
Cleared Jun 30, 2011
OCTANE-C INTERBODY FUSION DEVICE SYSTEM
K103655 · ODP
Exactech, Inc.
Orthopedic · 197d
Cleared Jun 08, 2011
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE...
K111379 · KWS
Exactech, Inc.
Orthopedic · 22d
Cleared May 17, 2011
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
K110706 · KWT
Exactech, Inc.
Orthopedic · 64d
Cleared Apr 01, 2011
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE /...
K110708 · PHX
Exactech, Inc.
Orthopedic · 18d
Cleared Jan 21, 2011
EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM
K102870 · MNH
Exactech, Inc.
Orthopedic · 113d
Cleared Dec 13, 2010
EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM
K103419 · KWS
Exactech, Inc.
Orthopedic · 21d
Cleared Nov 10, 2010
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD,...
K103012 · LZO
Exactech, Inc.
Orthopedic · 29d
Cleared Nov 08, 2010
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA...
K102487 · LZO
Exactech, Inc.
Orthopedic · 70d
Cleared Nov 05, 2010
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE
K102975 · LPH
Exactech, Inc.
Orthopedic · 30d
Cleared Nov 04, 2010
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL...
K102951 · PHX
Exactech, Inc.
Orthopedic · 30d
Cleared Sep 21, 2010
EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL...
K101761 · LPH
Exactech, Inc.
Orthopedic · 90d
Cleared Sep 02, 2010
EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE,...
K093430 · KWS
Exactech, Inc.
Orthopedic · 303d
Cleared Aug 02, 2010
OPTETRAK LOGIC COMBINATION TIBIAL TRAY
K101981 · JWH
Exactech, Inc.
Orthopedic · 19d
Cleared Aug 02, 2010
EXACTECH EQUINOXE, PLATFORM FRACTURE STEM
K101909 · PHX
Exactech, Inc.
Orthopedic · 25d
Cleared May 27, 2010
NOVATION CROWN CUP GXL LINERS
K100269 · LPH
Exactech, Inc.
Orthopedic · 118d
Cleared May 27, 2010
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER
K093275 · PHX
Exactech, Inc.
Orthopedic · 220d
Cleared May 11, 2010
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
K093978 · HRS
Exactech, Inc.
Orthopedic · 138d