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
13609–13632 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 18, 1998
SCS SPINAL SYSTEM
K983353 · KWP
Orthotec, Inc.
Orthopedic · 86d
Cleared Dec 18, 1998
STRYKER WEDGE SUTURE ANCHOR
K983557 · MBI
Stryker Endoscopy
Orthopedic · 66d
Cleared Dec 18, 1998
SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS
K983733 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 57d
Cleared Dec 18, 1998
DEPUY ORTHOTECH SPIKED WASHER
K983906 · HTN
DePuy Orthopaedics, Inc.
Orthopedic · 45d
Cleared Dec 18, 1998
OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS
K984302 · MNH
Osteonics Corp.
Orthopedic · 16d
Cleared Dec 17, 1998
NEW ZIMMER SHOULDER SYSTEM
K982981 · KWT
Zimmer, Inc.
Orthopedic · 113d
Cleared Dec 16, 1998
IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT
K980637 · JWH
Implex Corp.
Orthopedic · 300d
Cleared Dec 16, 1998
DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION
K980925 · JWH
Howmedica Corp.
Orthopedic · 280d
Cleared Dec 16, 1998
DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
K980926 · JDI
Howmedica Corp.
Orthopedic · 280d
Cleared Dec 16, 1998
POLYMER THREADED ANCHOR
K983169 · MBI
Orthopaedic Biosystems, Ltd.
Orthopedic · 97d
Cleared Dec 16, 1998
SYNTEC-TAICHUNG NON-STERILE BONE PLATE AND SCREW IMPLANTS, MODEL#'S...
K983495 · HWC
Syntec Scientific Corp.
Orthopedic · 72d
Cleared Dec 16, 1998
OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM
K983502 · LPH
Osteonics Corp.
Orthopedic · 71d
Cleared Dec 16, 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K983530 · KWP
Synthes (Usa)
Orthopedic · 69d
Cleared Dec 16, 1998
DYNA-LOK SPINAL SYSTEM
K983672 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 58d
Cleared Dec 16, 1998
PEDIATRIC CANNULATED OSTEOTOMY PLATES
K983967 · HRS
Biomet, Inc.
Orthopedic · 40d
Cleared Dec 16, 1998
OSTEO 9MM IC TIBIAL NAIL
K984353 · HSB
Osteonics Corp.
Orthopedic · 9d
Cleared Dec 11, 1998
DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION
K980626 · JDI
Howmedica Corp.
Orthopedic · 296d
Cleared Dec 11, 1998
DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION
K980632 · JWH
Howmedica Corp.
Orthopedic · 295d
Cleared Dec 11, 1998
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
K983382 · MEH
Osteonics Corp.
Orthopedic · 77d
Cleared Dec 07, 1998
KSEA C-MOUNT ARTHROSCOPES
K983142 · HRX
Karl Storz Endoscopy
Orthopedic · 90d
Cleared Dec 07, 1998
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K983508 · HWC
Osteonics Corp.
Orthopedic · 61d
Cleared Dec 04, 1998
ULNAR HEAD IMPLANT
K982268 · KXE
Avanta Orthopaedics, Inc.
Orthopedic · 158d
Cleared Dec 04, 1998
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
K982812 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 115d
Cleared Dec 04, 1998
NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS
K983153 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 86d