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
11449–11472 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 16, 2004
SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES
K042895 · KTT
Synthes (Usa)
Orthopedic · 27d
Cleared Nov 13, 2004
ASCENSION PYROSPHERE (PCS)
K042690 · KYI
Ascension Orthopedics, Inc.
Orthopedic · 45d
Cleared Nov 12, 2004
TOE MP JOINT, MODELS 10412-10414, 14958, 14960,...
K041595 · KWD
Biopro, Inc.
Orthopedic · 151d
Cleared Nov 12, 2004
OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
K042914 · MBI
Opus Medical, Inc.
Orthopedic · 22d
Cleared Nov 09, 2004
SPIRALOK ANCHOR
K041069 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 197d
Cleared Nov 09, 2004
FASTIN RC ANCHOR
K041075 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 197d
Cleared Nov 09, 2004
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
K041170 · LZO
Howmedica Osteonics Corp.
Orthopedic · 189d
Cleared Nov 09, 2004
X-SERIES INTEGRAL RPP FEMORAL COMPONENTS
K042029 · LPH
Biomet, Inc.
Orthopedic · 104d
Cleared Nov 09, 2004
NOVATION 12/14 PRESS-FIT FEMORAL STEM
K042842 · LZO
Exactech, Inc.
Orthopedic · 26d
Cleared Nov 05, 2004
ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE
K042796 · HWC
Coapt Systems, Inc.
Orthopedic · 29d
Cleared Nov 04, 2004
METAL/METAL HIP SYSTEM
K040354 · KWA
Encore Medical, L.P.
Orthopedic · 266d
Cleared Nov 04, 2004
ARTHREX TRIMIT FAMILY
K041189 · HWC
Arthrex, Inc.
Orthopedic · 182d
Cleared Nov 04, 2004
ARTHREX TENODESIS SCREW FAMILY
K041356 · HWC
Arthrex, Inc.
Orthopedic · 168d
Cleared Nov 04, 2004
MSD SILO SPINAL SYSTEM
K042210 · MNI
Medtronic Sofamor Danek
Orthopedic · 80d
Cleared Nov 04, 2004
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K042337 · LPH
Zimmer, Inc.
Orthopedic · 66d
Cleared Nov 04, 2004
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL...
K042776 · LPH
Zimmer, Inc.
Orthopedic · 29d
Cleared Nov 04, 2004
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
K042778 · HWC
Linvatec Corp.
Orthopedic · 29d
Cleared Nov 04, 2004
CD HORIZON SPINAL SYSTEM
K042790 · NKB
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Nov 04, 2004
C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM
K042798 · KWQ
Interpore Cross Intl.
Orthopedic · 27d
Cleared Nov 01, 2004
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · HRY
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 29, 2004
NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K041100 · MBH
Zimmer, Inc.
Orthopedic · 185d
Cleared Oct 29, 2004
TI - SCREW ANCHOR SP
K042460 · MBI
Arthrotek, Inc.
Orthopedic · 49d
Cleared Oct 29, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES
K042598 · HRS
Zimmer, Inc.
Orthopedic · 36d
Cleared Oct 29, 2004
NCB PLATING SYSTEM
K042695 · HRS
Zimmer GmbH
Orthopedic · 29d