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
14113–14136 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 03, 1997
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT
K965204 · KYI
Avanta Orthopaedics, Inc.
Orthopedic · 159d
Cleared Jun 03, 1997
EASY ROD
K970950 · MNH
Acromed Corp.
Orthopedic · 81d
Cleared Jun 03, 1997
OSTEONICS RESTORATION ACETABULAR RING
K970957 · JDJ
Osteonics Corp.
Orthopedic · 78d
Cleared May 28, 1997
SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)
K971544 · HWE
Synthes (Usa)
Orthopedic · 30d
Cleared May 22, 1997
BIO-ANCHOR
K963369 · MAI
Linvatec Corp.
Orthopedic · 268d
Cleared May 22, 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF...
K970257 · HSB
Ferguson Medical
Orthopedic · 119d
Cleared May 22, 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE...
K970258 · HRS
Ferguson Medical
Orthopedic · 119d
Cleared May 22, 1997
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF...
K970280 · HSB
Ferguson Medical
Orthopedic · 119d
Cleared May 22, 1997
INTER-OP POROUS REVISION SHELL WITH SEALABLE SCREWHOLES
K970705 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared May 22, 1997
INTER-OP POROUS PROTRUSIO SHELL WITH SEALABLE SCREWHOLES
K970706 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 85d
Cleared May 22, 1997
DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE
K970758 · JWH
Howmedica Corp.
Orthopedic · 80d
Cleared May 22, 1997
OSTEONICS ACETABULAR WEDGE SYSTEM
K971422 · MEH
Osteonics Corp.
Orthopedic · 35d
Cleared May 21, 1997
TENOSCOPE
K970642 · HRX
Luxtec Corp.
Orthopedic · 90d
Cleared May 14, 1997
TENOSNARE
K970562 · HRX
Luxtec Corp.
Orthopedic · 90d
Cleared May 09, 1997
SYNTHES (U.S.A.) POLYPIN
K961608 · HTY
Synthes (Usa)
Orthopedic · 379d
Cleared May 09, 1997
TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM
K970748 · KTT
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 67d
Cleared May 09, 1997
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K970779 · LZN
Osteonics Corp.
Orthopedic · 66d
Cleared May 08, 1997
ACROMED PEDICLE SCREW
K965102 · MNH
Acromed Corp.
Orthopedic · 139d
Cleared May 08, 1997
EMPOWER ANTERIOR DIRECT SCREWS
K965224 · KWP
Smith & Nephew Richards, Inc.
Orthopedic · 129d
Cleared May 08, 1997
CENTRE-DRIVE DRILL-FREE SCREW
K971297 · HRS
KLS-Martin L.P.
Orthopedic · 30d
Cleared May 07, 1997
WRIGHT PLASTER OF PARIS PELLETS
K963562 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 244d
Cleared May 06, 1997
BIOSPHERE SUTURE ANCHOR
K963396 · MAI
Instrument Makar, Inc.
Orthopedic · 251d
Cleared May 05, 1997
PRESS-FIT HIP STEM
K964178 · LWJ
Encore Orthopedics, Inc.
Orthopedic · 199d
Cleared May 02, 1997
EBI SPINELINK SYSTEM
K964797 · KWQ
Electro-Biology, Inc.
Orthopedic · 154d