FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
11425–11448 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 06, 2004
NEXFLEX TOTAL HIP SYSTEM
K042252 · LPH
Alphatec/Nexmed
Orthopedic · 108d
Cleared Dec 02, 2004
MODULAR ARTHRODESIS NAIL
K042409 · HSB
Biomet, Inc.
Orthopedic · 90d
Cleared Dec 01, 2004
MX POLYAXIAL PEDICLE SCREW
K043001 · MNH
Scient'X
Orthopedic · 30d
Cleared Nov 24, 2004
KASIOS TCP
K042340 · MQV
Kasios Biomaterials
Orthopedic · 86d
Cleared Nov 24, 2004
KOBRA GPS FIXATION SYSTEM
K042859 · KWQ
Medtronic Vertelink, Inc.
Orthopedic · 40d
Cleared Nov 24, 2004
TRIGEN HINDFOOT FUSION NAIL
K043052 · HSB
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Nov 23, 2004
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K042544 · KWQ
Depuy Spine, Inc.
Orthopedic · 64d
Cleared Nov 23, 2004
UNI-THREAD SPINAL SYSTEM
K042640 · MNH
Spine Vision, Inc.
Orthopedic · 57d
Cleared Nov 23, 2004
SILHOUETTE SPINAL FIXATION SYSTEM
K042702 · NKB
Zimmer Spine, Inc.
Orthopedic · 54d
Cleared Nov 23, 2004
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT
K042883 · JWH
Howmedica Osteonics Corp.
Orthopedic · 35d
Cleared Nov 23, 2004
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER...
K043061 · KWS
Zimmer Trabecular
Orthopedic · 18d
Cleared Nov 23, 2004
THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
K043082 · KWQ
Signus Medizintechnik GmbH
Orthopedic · 15d
Cleared Nov 22, 2004
PERFECTA FEMORAL STEM
K031402 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 567d
Cleared Nov 22, 2004
MODIFICATION TO PROTEX STABILIZATION SYSTEM
K042953 · NKB
Globus Medical, Inc.
Orthopedic · 27d
Cleared Nov 22, 2004
MX MONOAXIAL PEDICLE SCREW
K042964 · MNH
Scient'X
Orthopedic · 26d
Cleared Nov 19, 2004
SMITH & NEPHEW MODULAR HIP
K042127 · MEH
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Nov 19, 2004
VENTURE ANTERIOR CERVICAL PLATING SYSTEM
K042922 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Nov 19, 2004
DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H
K042966 · MAI
Linvatec Biomaterials, Ltd.
Orthopedic · 22d
Cleared Nov 18, 2004
CD HORIZON SPINAL SYSTEM
K042886 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 17, 2004
ALUMINA HEAD
K042035 · LZO
Fournitures Hospitalieres Industrie
Orthopedic · 111d
Cleared Nov 17, 2004
WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES
K042761 · KTT
Zimmer, Inc.
Orthopedic · 43d
Cleared Nov 17, 2004
MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM
K042986 · GXR
Synthes (Usa)
Orthopedic · 19d
Cleared Nov 16, 2004
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
K041443 · LZO
Osteoimplant Technology, Inc.
Orthopedic · 168d
Cleared Nov 16, 2004
ORTHOFIX VOLAR DISTAL RADIAL PLATE
K042766 · HRS
Orthofix, Inc.
Orthopedic · 42d