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
14233–14256 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 06, 1997
LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS
K963741 · HRS
Howmedica Leibinger, Inc.
Orthopedic · 142d
Cleared Feb 06, 1997
DEPUY DUPONT PHANTOM SUTURE ANCHOR
K964521 · MAI
Depuy, Inc.
Orthopedic · 86d
Cleared Feb 06, 1997
TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM
K964623 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 80d
Cleared Feb 06, 1997
UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
K964655 · JDI
Howmedica Corp.
Orthopedic · 78d
Cleared Feb 06, 1997
ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K964786 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 69d
Cleared Feb 03, 1997
HEDROCEL ACETABULAR RESTRICTOR
K962468 · JDI
Implex Corp.
Orthopedic · 223d
Cleared Feb 03, 1997
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
K963671 · JDI
Osteonics Corp.
Orthopedic · 143d
Cleared Feb 03, 1997
RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
K964472 · KYI
Biologically Oriented Prostheses
Orthopedic · 88d
Cleared Feb 03, 1997
MULTITAK SS SUTURE SYSTEM
K964532 · MBI
Bonutti Research
Orthopedic · 83d
Cleared Jan 28, 1997
EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM
K964919 · HRX
Emerald Medical, Inc.
Orthopedic · 50d
Cleared Jan 27, 1997
GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRON
K963509 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 146d
Cleared Jan 27, 1997
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
K963946 · LPH
Osteonics Corp.
Orthopedic · 117d
Cleared Jan 27, 1997
METAL BACKED ACETABULAR COMPONENT
K963998 · LPH
Encore Orthopedics, Inc.
Orthopedic · 112d
Cleared Jan 27, 1997
NATURAL-HIP SYSTEM COCR STEM
K964357 · LZO
Intermedics Orthopedics
Orthopedic · 87d
Cleared Jan 27, 1997
PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT
K964395 · LZO
Hayes Medical, Inc.
Orthopedic · 84d
Cleared Jan 24, 1997
FINN ROD TO ROD CONNECTOR
K960444 · KWP
Smith & Nephew Richards, Inc.
Orthopedic · 358d
Cleared Jan 24, 1997
DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
K964704 · LZO
Depuy, Inc.
Orthopedic · 60d
Cleared Jan 24, 1997
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
K965156 · KWL
Johnson & Johnson Professionals, Inc.
Orthopedic · 32d
Cleared Jan 22, 1997
MEDOFF SLIDING PLATE (PROPOSED NAME)
K962251 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 224d
Cleared Jan 22, 1997
STRYKER TEMPEST ORTHOPEDIC PUMP
K963304 · HRX
Stryker Endoscopy
Orthopedic · 153d
Cleared Jan 22, 1997
LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS
K963739 · HWC
Howmedica Leibinger, Inc.
Orthopedic · 127d
Cleared Jan 22, 1997
NORTHWEST PRECISION TECHNOLOGIES 6.5 MM CANNULATED CANNULATED CANCELLOUS SCREW
K963937 · HWC
Northwest Precision Technologies
Orthopedic · 113d
Cleared Jan 22, 1997
AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT
K964381 · KYI
Avanta Orthopaedics, Inc.
Orthopedic · 79d
Cleared Jan 17, 1997
ORTHODOC PREOPERATIVE PLANNER MODEL 500
K960685 · HWT
Integrated Surgical Systems, Inc.
Orthopedic · 332d