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
12361–12384 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 21, 2002
SYNTHES HIGH TIBIAL OSTEOTOMY PLATE
K014197 · HRS
Synthes (Usa)
Orthopedic · 90d
Cleared Mar 21, 2002
MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM
K020522 · MQP
Depuyacromed
Orthopedic · 30d
Cleared Mar 18, 2002
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW DB1 THREAD, MODEL F25-XX-09
K014154 · HWC
Vilex, Inc.
Orthopedic · 90d
Cleared Mar 18, 2002
OPENING/CLOSING WEDGE OSTETOMY PLATES
K014155 · HRS
Arthrex, Inc.
Orthopedic · 89d
Cleared Mar 18, 2002
CERASORB ORTHO
K014156 · MQV
Curasan AG
Orthopedic · 89d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012778 · JWH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE...
K012787 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE...
K012788 · KWS
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Mar 15, 2002
COAPT SYSTMES ENDOTINE DEVICE
K014153 · HWC
Coapt Systems, Inc.
Orthopedic · 87d
Cleared Mar 15, 2002
ADVANCE UNICONDYLAR KNEE SYSTEM
K014171 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 85d
Cleared Mar 15, 2002
STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
K020097 · JDW
Stryker Endoscopy
Orthopedic · 64d
Cleared Mar 14, 2002
MITEK BIOCRYL INTERFERENCE SCREWS
K013572 · HWC
Mitek Products
Orthopedic · 136d
Cleared Mar 12, 2002
HIGHGATE CURVED ROD SYSTEM
K012045 · KWQ
Highgate Orthopaedics
Orthopedic · 256d
Cleared Mar 12, 2002
GREAT TOE IMPLANT SYSTEM
K014164 · KWD
Harmos Orthopaedics, Inc.
Orthopedic · 83d
Cleared Mar 12, 2002
NUVASIVE TRIAD FACET SCREW SYSTEM
K020411 · MRW
Nuvasive, Inc.
Orthopedic · 33d
Cleared Mar 11, 2002
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
K012377 · HSD
Corin USA
Orthopedic · 228d
Cleared Mar 11, 2002
ENDIUS SPINAL FIXATION SYSTEM
K014090 · KWP
Endius, Inc.
Orthopedic · 90d
Cleared Mar 08, 2002
CONDUIT TCP GRANULES
K014053 · MQV
Depuyacromed
Orthopedic · 88d
Cleared Mar 08, 2002
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH)
K014072 · KWY
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 88d
Cleared Mar 08, 2002
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
K020403 · KTT
Ebi, L.P.
Orthopedic · 29d
Cleared Mar 07, 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 213d
Cleared Mar 04, 2002
WRISTORE FIXATOR
K012294 · KTT
Millennium Medical Technologies, Inc.
Orthopedic · 227d
Cleared Mar 04, 2002
TRIDENT ELEVATED RIM LINER
K020497 · LPH
Howmedica Osteonics Corp.
Orthopedic · 18d
Cleared Mar 04, 2002
ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM
K020572 · MEH
Howmedica Osteonics Corp.
Orthopedic · 11d