FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
14689–14712 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 05, 1996
OSTEONICS SHOULDER HUMERAL COMPONENTS
K955731 · KWS
Osteonics Corp.
Orthopedic · 78d
Cleared Mar 04, 1996
J.B.S. T.T.A SCREW
K955710 · HWC
J.B.S. (Usa), Inc.
Orthopedic · 81d
Cleared Mar 04, 1996
BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM
K955768 · MAI
Bioscience, Inc.
Orthopedic · 73d
Cleared Mar 04, 1996
CANNULATED PLUS HIP SCREW (STERILE)
K955837 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 69d
Cleared Feb 29, 1996
BIO-ANCHOR
K955486 · MAI
Linvatec Corp.
Orthopedic · 90d
Cleared Feb 27, 1996
ORTHOPLUG HARD BONE DESIGN
K955631 · LZN
Sunmed, Inc.
Orthopedic · 78d
Cleared Feb 27, 1996
ORTHOPLUG SOFT BONE DESIGN
K955632 · LZN
Sunmed, Inc.
Orthopedic · 78d
Cleared Feb 26, 1996
OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY
K954208 · JWH
Exactech, Inc.
Orthopedic · 172d
Cleared Feb 26, 1996
ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP
K955511 · LPH
Joint Medical Products Corp.
Orthopedic · 84d
Cleared Feb 21, 1996
SPINE SYSTEM SACRAL PLATE
K953881 · MNH
J.B.S., S.A.
Orthopedic · 187d
Cleared Feb 21, 1996
OSTEONICS N2/VAC PACKAGING PROCESS
K955421 · JWH
Osteonics Corp.
Orthopedic · 85d
Cleared Feb 21, 1996
CONSENSUS 26MM COCRMO FEMORAL HEAD
K960151 · JDI
U.S. Medical Products, Inc.
Orthopedic · 41d
Cleared Feb 21, 1996
CONSENSUS 32MM COCRMO FEMORAL HEAD
K960156 · JDI
U.S. Medical Products, Inc.
Orthopedic · 41d
Cleared Feb 21, 1996
CONSENSUS 22MM COCRMO FEMORAL HEAD
K960339 · JDI
U.S. Medical Products, Inc.
Orthopedic · 28d
Cleared Feb 20, 1996
PRELOADED SOFT TISSUE ANCHOR
K953954 · MBI
Linvatec Corp.
Orthopedic · 182d
Cleared Feb 20, 1996
CONSENSUS ZIRCONIA FEMORAL HEAD
K955386 · LZO
U.S. Medical Products, Inc.
Orthopedic · 90d
Cleared Feb 20, 1996
PRIME CEMENTED CALCAR FEMORAL STEMS
K955620 · JDI
Orthopaedic Innovations, Inc.
Orthopedic · 71d
Cleared Feb 16, 1996
TITANIUM MOSS MIAMI SPINAL SYSTEM
K955348 · KWP
Depuy, Inc.
Orthopedic · 87d
Cleared Feb 16, 1996
BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM
K955350 · LZO
Biomet, Inc.
Orthopedic · 87d
Cleared Feb 16, 1996
GAMMA SYSTEM
K955473 · JDI
Zimmer, Inc.
Orthopedic · 78d
Cleared Feb 15, 1996
MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE)
K953915 · MNH
Depuy, Inc.
Orthopedic · 178d
Cleared Feb 15, 1996
ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW
K954246 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 157d
Cleared Feb 15, 1996
INTERMOORE FRACTURE HIP STEM
K954854 · LWJ
Intermedics Orthopedics
Orthopedic · 115d
Cleared Feb 15, 1996
HOWMEDICA BIOABSORBABLE PIN
K955806 · HTY
Howmedica, Inc.
Orthopedic · 55d