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
12625–12648 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 12, 2002
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
K020083 · HRX
Tuta Healthcare Pty Limited
Orthopedic · 33d
Cleared Feb 12, 2002
NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA
K020295 · JWH
Implex Corp.
Orthopedic · 15d
Cleared Feb 11, 2002
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
K020170 · LPH
Encore Orthopedics, Inc.
Orthopedic · 25d
Cleared Feb 08, 2002
CONCERT RADIOPAQUE BONE CEMENT
K013755 · LOD
Immedica, Inc.
Orthopedic · 87d
Cleared Feb 08, 2002
SYNTHES METALLIC SPIKED WASHERS
K013806 · HTN
Synthes (Usa)
Orthopedic · 85d
Cleared Feb 08, 2002
REPICCI II UNICONDYLAR KNEE SYSTEM
K020264 · HRY
Biomet Orthopedics, Inc.
Orthopedic · 14d
Cleared Feb 06, 2002
RIDIDFIX 2.7MM BTB CROSS PIN KIT
K013781 · HTY
Mitek Products
Orthopedic · 84d
Cleared Feb 06, 2002
MODIFICATION TO GEO STRUCTURE
K020048 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Feb 05, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K020141 · KTT
Ebi, L.P.
Orthopedic · 20d
Cleared Feb 05, 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155 · KWP
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Feb 04, 2002
REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS
K012676 · HWE
Adven Medical
Orthopedic · 174d
Cleared Feb 04, 2002
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
K012694 · HWE
Adven Medical
Orthopedic · 174d
Cleared Feb 01, 2002
BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS
K013885 · MNI
Blackstone Medical, Inc.
Orthopedic · 70d
Cleared Feb 01, 2002
MODIFICATION TO ISOBAR SPINAL SYSTEM
K020245 · MNH
Scien'Tx USA, Inc.
Orthopedic · 8d
Cleared Jan 30, 2002
SPIKED WASHER
K011583 · HTN
Synthes (Usa)
Orthopedic · 252d
Cleared Jan 30, 2002
BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM
K012184 · KWQ
Blackstone Medical, Inc.
Orthopedic · 202d
Cleared Jan 30, 2002
LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE
K012551 · KWI
Biomet, Inc.
Orthopedic · 176d
Cleared Jan 30, 2002
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
K012702 · JWH
Endotec, Inc.
Orthopedic · 169d
Cleared Jan 30, 2002
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
K013196 · KWP
Spinal Innovations, LLC
Orthopedic · 127d
Cleared Jan 30, 2002
3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM
K020045 · KWT
Biomet Orthopedics, Inc.
Orthopedic · 23d
Cleared Jan 30, 2002
PATRIOT PROTRUSIO CAGE
K020076 · JDI
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Jan 29, 2002
PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K013665 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 84d
Cleared Jan 28, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
K010378 · MQP
Implex Corp.
Orthopedic · 354d
Cleared Jan 28, 2002
DEPUY FEMORAL HEADS
K011533 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 255d