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
12625–12648 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 02, 2001
ADVANCE UNICONDYLAR KNEE SYSTEM
K012591 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 84d
Cleared Oct 30, 2001
PALAMED BONE CEMENT
K010586 · LOD
Merck Biomaterial GmbH
Orthopedic · 245d
Cleared Oct 29, 2001
THEKEN LARGE CEMENT RESTRICTOR
K012462 · JDK
Theken Surgical,Llc
Orthopedic · 89d
Cleared Oct 29, 2001
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
K012465 · MAI
Bonutti Research, Inc.
Orthopedic · 89d
Cleared Oct 26, 2001
OSTEOSET BVF KIT
K010532 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 245d
Cleared Oct 24, 2001
LIFT VB SPINAL SYSTEM
K010930 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 210d
Cleared Oct 24, 2001
PASS SPINAL SYSTEM
K013191 · MNI
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 22, 2001
METAL SCREW ANCHOR
K012503 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 80d
Cleared Oct 19, 2001
AML HIP PROSTHESIS
K012364 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Oct 18, 2001
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
K012961 · JDI
Sulzer Orthopedics, Inc.
Orthopedic · 44d
Cleared Oct 17, 2001
THEKEN SMALL CEMENT RESTRICTOR
K012278 · JDK
Theken Surgical,Llc
Orthopedic · 90d
Cleared Oct 16, 2001
VBR
K012254 · MQP
Osteotech, Inc.
Orthopedic · 90d
Cleared Oct 16, 2001
VANGUARD REPROCESSED ARTHROSCOPIC BLADES
K012346 · HRX
Vanguard Medical Concepts, Inc.
Orthopedic · 84d
Cleared Oct 12, 2001
BIOCUFF,C, MODELS 236018, 236028, 236036
K013057 · MAI
Bionx Implants, Inc.
Orthopedic · 30d
Cleared Oct 11, 2001
EPOCA CUSTOM OFFSET SHOULDER SYSTEM
K010869 · KWT
Argomedical AG
Orthopedic · 202d
Cleared Oct 10, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 229d
Cleared Oct 10, 2001
DURACON PS LIPPED TIBIAL INSERT
K012172 · JWH
Howmedica Osteonics
Orthopedic · 90d
Cleared Oct 10, 2001
DISCOVERY ELBOW
K013042 · JDC
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 09, 2001
MONARCH SPINAL SYSTEMS
K013294 · MNH
Depuyacromed
Orthopedic · 7d
Cleared Oct 09, 2001
TIMX SPINAL SYSTEMS
K013295 · MNH
Depuyacromed
Orthopedic · 7d
Cleared Oct 09, 2001
MOSS MIAMI SPINAL SYSTEMS
K013296 · MNH
Depuyacromed
Orthopedic · 7d
Cleared Oct 05, 2001
ISOLA SPINAL SYSTEMS
K012971 · MNH
Depuyacromed
Orthopedic · 30d
Cleared Oct 04, 2001
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING...
K012967 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Oct 04, 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d