FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
11233–11256 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Oct 27, 2004
EBI CAS SPINE SPACER SYSTEM
K042268 · MQP
Ebi, L.P.
Orthopedic · 65d
Cleared Oct 27, 2004
SYNTHES (USA) LCP WRIST FUSION PLATES
K042355 · HRS
Synthes (Usa)
Orthopedic · 57d
Cleared Oct 27, 2004
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K042673 · KWP
Alphatec/Nexmed
Orthopedic · 28d