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
14257–14280 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared May 02, 1997
PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT
K970490 · LZO
Stelkast Company
Orthopedic · 81d
Cleared May 02, 1997
ACPII ANTERIOR CERVICAL PLATE SYSTEM
K970806 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 58d
Cleared Apr 30, 1997
STRYKER 2115 REPLACEMENT BATTERY (2115)
K970378 · KIJ
Implant Resource, Inc.
Orthopedic · 89d
Cleared Apr 30, 1997
INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE
K970423 · MBI
Innovasive Devices, Inc.
Orthopedic · 85d
Cleared Apr 30, 1997
IMPLEX BIPOLAR HIP SYSTEM
K970447 · KWY
Implex Corp.
Orthopedic · 83d
Cleared Apr 30, 1997
NATURAL-KNEE II REVISION FEMORAL SPACER LUGS
K970498 · JWH
Intermedics Orthopedics
Orthopedic · 79d
Cleared Apr 30, 1997
PEGGED ACETABULAR COMPONENT
K970501 · LPH
Biomet, Inc.
Orthopedic · 79d
Cleared Apr 30, 1997
DEPUY ACE TROCHANTERIC SIDE PLATE
K970503 · HRS
Depuy Ace Medical Co.
Orthopedic · 79d
Cleared Apr 30, 1997
TITANIUM ALLOY BONE SCREWS
K970549 · HWC
Aesculap, Inc.
Orthopedic · 77d