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
12601–12624 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 16, 2001
LONG LENGTH DYAX NAIL
K013468 · HSB
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Nov 16, 2001
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
K013503 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 25d
Cleared Nov 16, 2001
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
K013557 · MBI
Walter Lorenz Surgical, Inc.
Orthopedic · 23d
Cleared Nov 15, 2001
PASS SPINAL SYSTEM
K013431 · MNI
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Nov 14, 2001
CONVERGE ACETABULAR SYSTEM
K012739 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Nov 14, 2001
HEALOS BONE GRAFT MATERIAL
K012751 · MQV
Orquest, Inc.
Orthopedic · 90d
Cleared Nov 14, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K013403 · MNI
Endius, Inc.
Orthopedic · 30d
Cleared Nov 14, 2001
TROCHANTERIC DYAX NAIL SYSTEM
K013524 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 13, 2001
BSM BONE SUBSTITUTE MATERIAL
K011048 · MQV
DePuy Orthopaedics, Inc.
Orthopedic · 221d
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