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
11857–11880 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
K032032 · HRS
Synthes (Usa)
Orthopedic · 65d
Cleared Sep 04, 2003
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
K032037 · MNI
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Sep 04, 2003
HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K032479 · JWH
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Sep 03, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031833 · MNI
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Sep 02, 2003
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
K031729 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Aug 29, 2003
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K024313 · MNI
Pisharodi Surgicals, Inc.
Orthopedic · 248d
Cleared Aug 29, 2003
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
K030237 · KWI
Kapp Surgical Instrument, Inc.
Orthopedic · 218d
Cleared Aug 29, 2003
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
K031730 · JDI
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Aug 29, 2003
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K032409 · MQV
Orthovita, Inc.
Orthopedic · 25d
Cleared Aug 29, 2003
S2 NAIL SYSTEM
K032579 · HSB
Howmedica Osteonics Corp.
Orthopedic · 8d
Cleared Aug 28, 2003
INION OTPS BIODEGRADABLE PIN
K031712 · HTY
Inion , Ltd.
Orthopedic · 87d
Cleared Aug 25, 2003
MITEK MICRO QUICKANCHOR
K032078 · NOV
Mitek Worldwide
Orthopedic · 49d
Cleared Aug 22, 2003
OSTEOMED SUBTALAR IMPLANT SYSTEM
K031155 · HWC
Osteomed LP
Orthopedic · 133d
Cleared Aug 22, 2003
TRAXIS CEMENT RESTRICTOR
K031318 · JDK
Spinal Concepts, Inc.
Orthopedic · 119d
Cleared Aug 22, 2003
STRYKER SPINE OASYS BONE SCREW
K031657 · MRW
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Aug 21, 2003
COLUMBUS (PS)
K030367 · JWH
Aesculap, Inc.
Orthopedic · 198d
Cleared Aug 21, 2003
SYNTHES (USA) CALVICLE HOOK PLATE
K031677 · HRS
Synthes (Usa)
Orthopedic · 83d
Cleared Aug 21, 2003
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
K032295 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 21, 2003
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
K032396 · JDI
Biomet, Inc.
Orthopedic · 17d
Cleared Aug 20, 2003
MODIFICATION ORIA SPINAL SYSTEM
K023884 · KWP
Ortho Tec, LLC
Orthopedic · 272d
Cleared Aug 13, 2003
MODIFICATION TO CERASORB ORTHO
K031651 · MQV
Curasan AG
Orthopedic · 77d
Cleared Aug 12, 2003
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 188d
Cleared Aug 12, 2003
ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL
K032367 · HSB
Zimmer, Inc.
Orthopedic · 11d
Cleared Aug 11, 2003
MALLORY/HEAD TOTAL HIP SYSTEM
K030055 · LPH
Biomet, Inc.
Orthopedic · 217d