FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
16129–16152 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 27, 1991
EXACTECH BIPOLAR HIP PROSTHESIS
K905370 · KWY
Exactech, Inc.
Orthopedic · 90d
Cleared Feb 26, 1991
THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH
K905254 · LWJ
Depuy, Inc.
Orthopedic · 95d
Cleared Feb 21, 1991
EXTERNAL FIXATION
K904973 · KTT
Dynasplint Systems, Inc.
Orthopedic · 115d
Cleared Feb 15, 1991
ISOLA(TM) SPINE SYSTEM TOP ENTRY HOOK
K905184 · KWP
Acromed Corp.
Orthopedic · 88d
Cleared Feb 15, 1991
GERI TOTAL HIP SYSTEM
K905186 · LWJ
Smith & Nephew Richards, Inc.
Orthopedic · 88d
Cleared Feb 13, 1991
WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT
K905076 · JWH
Dow Corning Wright
Orthopedic · 92d
Cleared Feb 05, 1991
CUP OUT
K905027 · HSZ
Anspach Mfg., Inc.
Orthopedic · 90d
Cleared Jan 30, 1991
ACE 3.5MM CORTICAL BONE SCREW
K905048 · HWC
Ace Medical Co.
Orthopedic · 83d
Cleared Jan 30, 1991
TOTAL HIP FEMORAL COMPONENT
K905260 · LZO
Intermedics Orthopedics
Orthopedic · 70d
Cleared Jan 28, 1991
BEUCHEL-PAPPAS GLENOID COMPONENT
K904879 · KWS
Endotec, Inc.
Orthopedic · 90d
Cleared Jan 28, 1991
BUECHEL-PAPPAS HUMERAL STEM COMPONENT
K904880 · KWS
Endotec, Inc.
Orthopedic · 90d
Cleared Jan 28, 1991
OSTEONICS(R) MPSS HIP STEM SERIES
K905275 · JDI
Osteonics Corp.
Orthopedic · 66d
Cleared Jan 18, 1991
MTS FEMORAL HIP SYSTEM
K903877 · KWL
3M Company
Orthopedic · 149d
Cleared Jan 15, 1991
HAWAIIAN SUPRACONDYLAR PLATE
K903697 · HRS
Medpac
Orthopedic · 153d
Cleared Jan 14, 1991
DCW MODULAR PROXIMAL FEMORAL SYSTEM
K904028 · LZO
Dow Corning Wright
Orthopedic · 136d
Cleared Jan 11, 1991
MODULAR UNIPOLAR SYSTEM
K902365 · KWL
Howmedica Corp.
Orthopedic · 226d
Cleared Jan 09, 1991
CTH STABILO TOTAL HIP REPLACEMENT SYSTEM
K903976 · LZO
Kinamed, Inc.
Orthopedic · 134d
Cleared Jan 08, 1991
MICRO-AIRE 4220-000 OSCILLATING SAW
K905277 · HSZ
Micro Surgical Instruments Corp.
Orthopedic · 46d
Cleared Jan 04, 1991
CONTAIN(TM) LASER PLUME FILTER
K902167 · JDY
Arbor Technologies, Inc.
Orthopedic · 234d
Cleared Jan 04, 1991
C FIT CUP
K903938 · JDI
Orthopedic Systems, Inc.
Orthopedic · 130d
Cleared Jan 04, 1991
BIOPRO TRINITY ACETABULAR CUP
K904207 · JDI
Biopro, Inc.
Orthopedic · 114d
Cleared Jan 04, 1991
SNAP-PAK (TM)
K905112 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 52d
Cleared Jan 04, 1991
OSTEONICS(R) 6011 HIP STEM SERIES
K905158 · JDI
Osteonics Corp.
Orthopedic · 49d
Cleared Jan 04, 1991
U.S. TYPE CRUCIATE SLOT BONE SCREW
K905333 · HWC
O'Tec Corp.
Orthopedic · 37d