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
11929–11952 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 10, 2003
DEPUY ACROMED VBR SYSTEM
K030833 · MQP
Depuyacromed
Orthopedic · 24d
Cleared Apr 10, 2003
AVANTA CARPAL FUSION PLATING SYSTEM
K030881 · HRS
Avanta Orthopaedics, Inc.
Orthopedic · 21d
Cleared Apr 10, 2003
AAP ACROPLATE
K030909 · HRS
Aap Implantate AG
Orthopedic · 17d
Cleared Apr 08, 2003
TETRIS SPINAL IMPLANT
K022793 · MQP
Signus Medical, LLC
Orthopedic · 228d
Cleared Apr 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS
K030858 · HRS
Synthes (Usa)
Orthopedic · 17d
Cleared Apr 02, 2003
KSEA POWERSHAVER SYSTEM S2
K030009 · HRX
Karl Storz Endoscopy
Orthopedic · 90d
Cleared Apr 02, 2003
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
K030686 · JWH
Exactech, Inc.
Orthopedic · 28d
Cleared Apr 02, 2003
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
K030736 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Apr 01, 2003
CONSTRAINED LINER
K023794 · KWZ
Encore Medical, L.P.
Orthopedic · 139d
Cleared Apr 01, 2003
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
K030153 · JDI
Zimmer, Inc.
Orthopedic · 75d
Cleared Apr 01, 2003
HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM
K030198 · HRS
Hand Innovations, Inc.
Orthopedic · 70d
Cleared Apr 01, 2003
CONSENSUS UNIPOLAR HEAD, COCR
K030205 · KWL
Hayes Medical, Inc.
Orthopedic · 70d
Cleared Apr 01, 2003
SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE
K030390 · LXT
Synthes (Usa)
Orthopedic · 55d
Cleared Apr 01, 2003
ODI 7.0MM CANNULATED SCREW SYSTEM
K030619 · HTN
Orthopedic Designs, Inc.
Orthopedic · 33d
Cleared Mar 28, 2003
BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE
K022965 · KWQ
Blackstone Medical, Inc.
Orthopedic · 203d
Cleared Mar 28, 2003
SPINAL CONCEPTS INC. PATHFINDER
K030625 · NKB
Spinal Concepts, Inc.
Orthopedic · 29d
Cleared Mar 25, 2003
PROVEN MODULAR TIBIAL TRAY
K030577 · JWH
Stelkast Company
Orthopedic · 29d
Cleared Mar 25, 2003
VERTE-STACK SPINAL SYSTEM
K030601 · MQP
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Mar 25, 2003
BONE WIRE
K030665 · HTY
Stork Instrumente GmbH
Orthopedic · 22d
Cleared Mar 24, 2003
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
K022949 · MNI
Synthes (Usa)
Orthopedic · 200d
Cleared Mar 20, 2003
STRYKER BIOZIP SUTURE ANCHOR
K023192 · HWC
Stryker Endoscopy
Orthopedic · 176d
Cleared Mar 20, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER
K023692 · LWJ
Howmedica Osteonics Corp.
Orthopedic · 136d
Cleared Mar 20, 2003
ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475
K024291 · HRX
Arthrex, Inc.
Orthopedic · 86d
Cleared Mar 20, 2003
KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
K030368 · HWC
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 44d