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
12289–12312 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 26, 2002
SYNTHES CERVIFIX/ AXON
K023675 · KWP
Synthes (Usa)
Orthopedic · 25d
Cleared Nov 25, 2002
ENDOTACK
K022853 · MBI
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 90d
Cleared Nov 25, 2002
METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022886 · KWH
Osteomed Corp.
Orthopedic · 87d
Cleared Nov 25, 2002
ASCENSION SILLICONE MCP
K022892 · KYJ
Ascension Orthopedics, Inc.
Orthopedic · 87d
Cleared Nov 25, 2002
MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM
K023644 · MNI
Spinal Concepts, Inc.
Orthopedic · 26d
Cleared Nov 22, 2002
ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR
K022827 · MBI
Linvatec Corp.
Orthopedic · 88d
Cleared Nov 22, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K023555 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Nov 21, 2002
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
K022799 · JDI
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Nov 20, 2002
OTI UNICONDULAR INTERPOSITIONAL SPACER
K022779 · HSH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Nov 19, 2002
ORIA SPINAL CLIP SYSTEM
K021679 · KWP
Ortho Tec, LLC
Orthopedic · 182d
Cleared Nov 19, 2002
CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES...
K022798 · KWQ
Corin USA
Orthopedic · 88d
Cleared Nov 19, 2002
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K023570 · MQP
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Nov 19, 2002
BIOBUCK CEMENT RESTRICTOR
K023680 · LZN
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Nov 14, 2002
VENTED CEMENT RESTRICTOR
K022729 · JDX
Amedica Corp.
Orthopedic · 90d
Cleared Nov 14, 2002
FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF...
K023437 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Nov 13, 2002
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING
K020703 · JWH
Howmedica Osteonics Corp.
Orthopedic · 254d
Cleared Nov 13, 2002
AMT POLYAXIAL PEDICLE SCREW
K022768 · MNI
Micron Precision Engineering, Inc.
Orthopedic · 84d
Cleared Nov 13, 2002
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
K022791 · KWQ
Synthes (Usa)
Orthopedic · 83d
Cleared Nov 13, 2002
MODIFICATION TO MONARCH SPINE SYSTEM
K023438 · MNH
Depuyacromed
Orthopedic · 29d
Cleared Nov 13, 2002
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K023453 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Nov 13, 2002
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K023498 · KWP
Blackstone Medical, Inc.
Orthopedic · 26d
Cleared Nov 13, 2002
MODIFICATION TO CLASSIC GREAT TOE IMPLANT
K023562 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 21d
Cleared Nov 13, 2002
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
K023646 · JDI
Exactech, Inc.
Orthopedic · 14d
Cleared Nov 08, 2002
COLUMBUS TOTAL KNEE SYSTEM (CR)
K022672 · JWH
Aesculap, Inc.
Orthopedic · 88d