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."
49–72 of 187
Search insights Median review: 86d Cleared: 100% Top manufacturer: Exactech, Inc. Lead specialty: Orthopedic
Cleared Apr 09, 2015
Equinoxe Mega Prosthesis
K143659 · KWT
Exactech, Inc.
Orthopedic · 107d
Cleared Feb 27, 2015
Exactech Ambassador
K143576 · KWQ
Exactech, Inc.
Orthopedic · 72d
Cleared Aug 28, 2014
ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7
K141821 · LZO
Exactech, Inc.
Orthopedic · 52d
Cleared Aug 15, 2014
EXACTECH CERVICAL SPACER SYSTEM
K141129 · ODP
Exactech, Inc.
Orthopedic · 106d
Cleared Jul 30, 2014
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
K140302 · MBH
Exactech, Inc.
Orthopedic · 174d
Cleared Jul 29, 2014
ALTEON 6.5MM BONE SCREWS
K141797 · LPH
Exactech, Inc.
Orthopedic · 27d
Cleared Jun 30, 2014
EXACTECH TAPERED WEDGE FEMORAL STEM
K140674 · LZO
Exactech, Inc.
Orthopedic · 104d
Cleared Apr 25, 2014
OCTANE ELEVATE SPINAL IMPLANT SYSTEM
K123607 · MAX
Exactech, Inc.
Orthopedic · 520d
Cleared Feb 12, 2014
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
K132582 · OVE
Exactech, Inc.
Orthopedic · 180d
Cleared Feb 11, 2014
EQUINOXE EXTRA SHORT HUMERAL HEAD
K140063 · KWS
Exactech, Inc.
Orthopedic · 32d
Cleared Nov 26, 2013
EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM
K131298 · HSD
Exactech, Inc.
Orthopedic · 204d
Cleared Oct 11, 2013
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM...
K132161 · JWH
Exactech, Inc.
Orthopedic · 91d
Cleared Jul 03, 2013
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID...
K131575 · PHX
Exactech, Inc.
Orthopedic · 33d
Cleared May 01, 2013
OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE...
K130434 · MAX
Exactech, Inc.
Orthopedic · 69d
Cleared Mar 20, 2013
OPTETRAK LOGIC POROUS FEMORAL COMPONENT
K123687 · JWH
Exactech, Inc.
Orthopedic · 107d
Cleared Feb 12, 2013
GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM...
K121877 · KWP
Exactech, Inc.
Orthopedic · 229d
Cleared Jan 16, 2013
NOVATION CROWN CUP LINERS
K121392 · LZO
Exactech, Inc.
Orthopedic · 252d
Cleared Jan 10, 2013
OPTETRAK LOGIC CRC TIBIAL INSERT
K123342 · JWH
Exactech, Inc.
Orthopedic · 71d
Cleared Dec 06, 2012
EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR...
K121067 · PHX
Exactech, Inc.
Orthopedic · 244d
Cleared Nov 27, 2012
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE +...
K121989 · MQV
Exactech, Inc.
Orthopedic · 144d
Cleared Nov 20, 2012
EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT
K121220 · KWS
Exactech, Inc.
Orthopedic · 211d
Cleared Oct 11, 2012
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
K122798 · LPH
Exactech, Inc.
Orthopedic · 29d
Cleared Oct 01, 2012
NOVATION LPI PRIME FEMORAL STEM
K121684 · LPH
Exactech, Inc.
Orthopedic · 116d
Cleared May 31, 2012
OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE...
K121307 · JWH
Exactech, Inc.
Orthopedic · 30d