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."

121–144 of 187

Search insights Median review: 86d Cleared: 100% Top manufacturer: Exactech, Inc. Lead specialty: Orthopedic

Cleared Dec 28, 2004

CEMEX SYSTEM GENTA FAST BONE CEMENT

Orthopedic · 18d

Cleared Nov 09, 2004

NOVATION 12/14 PRESS-FIT FEMORAL STEM

Orthopedic · 26d

Cleared Oct 26, 2004

EXACTECH EQUINOXE SHOULDER SYSTEM

Orthopedic · 90d

Cleared Oct 04, 2004

EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS

Orthopedic · 210d

Cleared Oct 01, 2004

EXACTECH OPTETRAK UNICONDYLAR KNEE

Orthopedic · 179d

Cleared Sep 10, 2004

EXACTECH 12/14 TOTAL HIP SYSTEM

Orthopedic · 57d

Cleared Jun 17, 2004

EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE

Orthopedic · 85d

Cleared Jun 04, 2004

EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS

Orthopedic · 87d

Cleared May 28, 2004

TECRES SPACER-K TEMPORARY KNEE PROSTHESIS

Orthopedic · 287d

Cleared May 10, 2004

CEMEX GENTA BONE CEMENT

Orthopedic · 178d

Cleared Feb 27, 2004

EXACTECH RESORBABLE BONE PASTE

Orthopedic · 779d

Cleared Feb 13, 2004

OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED...

Orthopedic · 60d

Cleared Jan 22, 2004

SPACER G TEMPORARY HIP PROSTHESIS

Orthopedic · 220d

Cleared Nov 13, 2003

EXACTECH 12/14 ALUMINA FEMORAL HEAD

Orthopedic · 51d

Cleared Sep 23, 2003

OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6...

Orthopedic · 29d

Cleared May 22, 2003

CEMEX SYSTEM FAST

Orthopedic · 16d

Cleared Apr 02, 2003

OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT

Orthopedic · 28d

Cleared Feb 20, 2003

ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT

Orthopedic · 28d

Cleared Nov 13, 2002

EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM

Orthopedic · 14d

Cleared Oct 17, 2002

OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY

Orthopedic · 23d

Cleared Aug 16, 2002

CEMENT RESTRICTOR, SMALL AND LARGE

Orthopedic · 79d

Cleared Jun 12, 2002

CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL

Orthopedic · 20d

Cleared Feb 27, 2002

EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER

Orthopedic · 30d

Cleared Dec 05, 2001

MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS

Orthopedic · 70d