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
15409–15432 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 10, 1994
SUTTER PROXIMAL INTERPHALANGEAL JOINT
K931588 · KYJ
Sutter Corp.
Orthopedic · 344d
Cleared Mar 10, 1994
OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM
K932519 · LZO
Osteonics Corp.
Orthopedic · 289d
Cleared Mar 10, 1994
RMHS POROUS DISTAL SLEEVE
K932574 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 287d
Cleared Mar 10, 1994
ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL
K932593 · HSB
Synthes (Usa)
Orthopedic · 286d
Cleared Mar 10, 1994
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
K932862 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 272d
Cleared Mar 10, 1994
ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL INSTRUMENTATION SYSTEM
K934044 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 203d
Cleared Mar 10, 1994
PROFORM HIP SYSTEM
K934161 · JDO
Stelkast Company
Orthopedic · 195d
Cleared Mar 09, 1994
REPLICA(TM) TOTAL HIP SYSTEM
K926156 · LPH
Osteo Technology, Inc.
Orthopedic · 457d
Cleared Mar 09, 1994
OSTEONICS OMNIFIT FORGED HIP STEM SERIES
K933561 · JDI
Osteonics Corp.
Orthopedic · 230d
Cleared Mar 09, 1994
PROFORM HA HIP SYSTEM
K934162 · JDO
Stelkast Company
Orthopedic · 194d
Cleared Mar 09, 1994
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K935078 · JDG
Joint Medical Products Corp.
Orthopedic · 135d
Cleared Mar 09, 1994
FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM
K935646 · JDQ
Biodynamic Technologies, Inc.
Orthopedic · 106d
Cleared Mar 09, 1994
FX-CABLELOK CABLE/PLATE SYSTEM
K935950 · JDQ
Buckman Co., Inc.
Orthopedic · 86d
Cleared Mar 07, 1994
BAUMER STAPLES
K930967 · JDR
Baumer Ortopedia , Ltd.
Orthopedic · 376d
Cleared Mar 07, 1994
GAMMA LOCKING NAIL-CROSS LOCKING SCREWS
K932174 · KTT
Howmedica Corp.
Orthopedic · 306d
Cleared Mar 07, 1994
OSTEONICS 22MM, +10 NECK BEARING HEADS
K933359 · LWJ
Osteonics Corp.
Orthopedic · 241d
Cleared Mar 07, 1994
BIOMETRIC TOTAL HIP SYSTEM
K935012 · JDI
Osteo-Technology Intl., Inc.
Orthopedic · 138d
Cleared Mar 03, 1994
OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS
K930187 · JDI
Osteonics Corp.
Orthopedic · 413d
Cleared Mar 03, 1994
ACETABULAR SHELL
K935731 · LPH
Howmedica Corp.
Orthopedic · 92d
Cleared Mar 01, 1994
IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM
K925153 · KWY
Howmedica Corp.
Orthopedic · 504d
Cleared Mar 01, 1994
FULLY THREADED ALTA CANCELLOUS BONE SCREW
K931524 · HWC
Howmedica Corp.
Orthopedic · 340d
Cleared Mar 01, 1994
ORTHOPEDIC SMOOTH PIN FIXATION
K932348 · HTY
Osteomed Corp.
Orthopedic · 291d
Cleared Mar 01, 1994
ORTHOPEDIC THREADED PIN FIXATION
K932349 · JDW
Osteomed Corp.
Orthopedic · 291d
Cleared Mar 01, 1994
PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE
K933875 · JDI
Howmedica Corp.
Orthopedic · 204d