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
12745–12768 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 09, 2001
REPROCESSED LINVATEC ARTHROSCOPIC BURS
K012630 · HRX
Alliance Medical, Inc.
Orthopedic · 88d
Cleared Nov 08, 2001
REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE,...
K012624 · HRX
Medical Instruments Technology, Inc.
Orthopedic · 87d
Cleared Nov 08, 2001
REPROCESSED DYONICS ARTHROSCOPIC BURS
K012652 · HRX
Alliance Medical Corp.
Orthopedic · 87d
Cleared Nov 08, 2001
EBI XFIX DFS SYSTEM
K013378 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Nov 07, 2001
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120,...
K010989 · MQP
Interpore Cross Intl.
Orthopedic · 218d
Cleared Nov 07, 2001
REPROCESSED ATHROSCOPICS BURS
K012605 · HRX
Alliance Medical Corp.
Orthopedic · 86d
Cleared Nov 07, 2001
REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
K012611 · HRX
Alliance Medical, Inc.
Orthopedic · 86d
Cleared Nov 07, 2001
REPROCSSED LINVATEC SHAVERS
K012613 · HRX
Alliance Medical, Inc.
Orthopedic · 86d
Cleared Nov 07, 2001
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS
K012635 · HRX
Alliance Medical Corp.
Orthopedic · 86d
Cleared Nov 07, 2001
CONGRUENT BONE PLATE SYSTEM
K012655 · HRS
Acu Med, Inc.
Orthopedic · 86d
Cleared Nov 07, 2001
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM
K013222 · MNI
Depuyacromed
Orthopedic · 41d
Cleared Nov 07, 2001
MODIFICATION TO DEPUY C-STEM SYSTEM
K013350 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Nov 07, 2001
MODIFICATION TO: STACKABLE CAGE SYSTEM
K013382 · MQP
Depuyacromed
Orthopedic · 26d
Cleared Nov 02, 2001
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
K011985 · MAI
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Nov 02, 2001
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES
K012536 · HRX
Sterilmed, Inc.
Orthopedic · 87d
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