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
14209–14232 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 24, 1997
INNOVASIVE DEVICES ROTATOR CUFF FASTNER
K964945 · MBI
Innovasive Devices, Inc.
Orthopedic · 76d
Cleared Feb 24, 1997
KINEMAX PLUS TIBIAL SPACERS
K964951 · JWH
Howmedica Corp.
Orthopedic · 76d
Cleared Feb 24, 1997
COHORT DISCECTOMY SYSTEMS (CDS)
K964975 · HRX
Cohort Medical Products Group, Inc.
Orthopedic · 74d
Cleared Feb 19, 1997
ANTERIOR DYNAMIZED SYSTEM
K953978 · KWQ
Acromed Corp.
Orthopedic · 546d
Cleared Feb 19, 1997
CEMENTED CALCAR REPLACEMENT FEMORAL STEM
K964795 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 82d
Cleared Feb 19, 1997
STABLELOC II EXTERNAL FIXATOR
K965029 · JEC
Acu Med, Inc.
Orthopedic · 64d
Cleared Feb 19, 1997
PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT
K970346 · LZO
Kairos Orthopaedics
Orthopedic · 20d
Cleared Feb 18, 1997
BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR...
K960363 · MJT
Biomet, Inc.
Orthopedic · 390d
Cleared Feb 18, 1997
STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR...
K965111 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d
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