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
14353–14376 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 13, 1997
SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM
K963045 · MNH
Synthes (Usa)
Orthopedic · 192d
Cleared Feb 13, 1997
NEXGEN COMPLETE KNEE SOLUTION
K963148 · JWH
Zimmer, Inc.
Orthopedic · 184d
Cleared Feb 13, 1997
EXETER MESH
K963940 · JDJ
Howmedica, Inc.
Orthopedic · 135d
Cleared Feb 13, 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
K964769 · LPH
Zimmer, Inc.
Orthopedic · 78d
Cleared Feb 13, 1997
IN-TAC BONE ANCHOR SYSTEM
K964953 · HXJ
Influence, Inc.
Orthopedic · 70d
Cleared Feb 12, 1997
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD...
K963100 · LPH
Endotec, Inc.
Orthopedic · 187d
Cleared Feb 12, 1997
B-P HEMISPHERICAL ACETABULAR COMPONENT
K963101 · LPH
Endotec, Inc.
Orthopedic · 187d
Cleared Feb 12, 1997
METAGEN HIGH TIBIAL OSTEOTOMY SYSTEM
K963700 · HRS
Metagen, LLC
Orthopedic · 149d
Cleared Feb 12, 1997
ANSPACH SUTURE ANCHOR
K965069 · MBI
The Anspach Effort, Inc.
Orthopedic · 61d
Cleared Feb 11, 1997
OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
K964544 · MNH
Osteonics Corp.
Orthopedic · 90d
Cleared Feb 07, 1997
STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE...
K964927 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d
Cleared Feb 06, 1997
METALLIC SPHERICAL CMC IMPLANT
K960534 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 365d
Cleared Feb 06, 1997
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
K960659 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 356d
Cleared Feb 06, 1997
RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)
K961498 · HRS
Howmedica, Inc.
Orthopedic · 294d
Cleared Feb 06, 1997
TITANIUM CD HORIZON SPINAL SYSTEM
K962708 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 209d
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