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
13081–13104 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 27, 2000
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
K001385 · KWI
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Jul 27, 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · HSD
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Jul 27, 2000
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
K001536 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 71d
Cleared Jul 27, 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K001745 · LWJ
Stelkast Company
Orthopedic · 49d
Cleared Jul 27, 2000
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
K002106 · JDI
Biomet, Inc.
Orthopedic · 15d
Cleared Jul 26, 2000
STACKABLE CAGE SYSTEM
K001340 · MQP
Depuyacromed
Orthopedic · 90d
Cleared Jul 26, 2000
PATIENT MATCHED TITANIUM ALLOY TROCHLEA
K001350 · KRR
Biomet, Inc.
Orthopedic · 89d
Cleared Jul 26, 2000
TRI-LOCK HIP STEM
K001982 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Jul 25, 2000
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
K001323 · MRW
Nuvasive, Inc.
Orthopedic · 90d
Cleared Jul 25, 2000
SL-PLUS AND SLR-PLUS STEMS
K001942 · LWJ
Plus Orthopedics
Orthopedic · 29d
Cleared Jul 25, 2000
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
K001957 · KRO
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Jul 25, 2000
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
K001989 · JDC
Zimmer, Inc.
Orthopedic · 26d
Cleared Jul 24, 2000
MACROSORBOS PROTECTIVE SHEET
K994158 · HRS
Macropore Biosurgery, Inc.
Orthopedic · 228d
Cleared Jul 20, 2000
MODIFICATION TO OMEGA 21 SYSTEM
K001357 · KWQ
Ebi, L.P.
Orthopedic · 83d
Cleared Jul 20, 2000
TI-MAX PROTRUSIO CAGE
K001376 · JDI
Biomet, Inc.
Orthopedic · 80d
Cleared Jul 20, 2000
SYNTHES CERVIFIX SYSTEM
K001864 · KWQ
Synthes Spine
Orthopedic · 30d
Cleared Jul 20, 2000
TORNIER CEMENT RESTRICTOR
K001932 · JDI
Tornier
Orthopedic · 24d
Cleared Jul 19, 2000
MODIFICATION TO CENTAUR SPINAL SYSTEM
K001844 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 19, 2000
GEM KNEE SYSTEM
K994214 · JWH
Kinamed, Inc.
Orthopedic · 218d
Cleared Jul 14, 2000
SAMARCO SPIDER PLATES
K001271 · KTW
Biomet, Inc.
Orthopedic · 85d
Cleared Jul 12, 2000
EBI ANTERIOR CERVICAL PLATE SYSTEM
K001794 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Jul 12, 2000
APEX FIXATION PINS
K001886 · JDW
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 11, 2000
THE KALIX IMPLANT
K001231 · HWC
New Deal, S.A.
Orthopedic · 85d
Cleared Jul 11, 2000
CD HORIZON SPINAL SYSTEM
K001255 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d