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
12265–12288 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 13, 2002
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797 · KWP
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Dec 12, 2002
K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM)
K023770 · KWD
Kinetikos Medical, Inc.
Orthopedic · 30d
Cleared Dec 11, 2002
BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
K021039 · KWQ
Depuyacromed
Orthopedic · 254d
Cleared Dec 11, 2002
PRESS-FIT HEAD RESURFACING DEVICE
K023188 · KXA
Biomet Orthopedics, Inc.
Orthopedic · 78d
Cleared Dec 11, 2002
T2 SUPRACONDYLAR NAIL SYSTEM
K023267 · HSB
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Dec 11, 2002
ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM
K023299 · MNI
Alphatec Mfg., Inc.
Orthopedic · 69d
Cleared Dec 11, 2002
ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153,...
K023777 · HRX
Arthronet Medical, Inc.
Orthopedic · 29d
Cleared Dec 10, 2002
CD HORIZON SPINAL SYSTEM
K014296 · KWP
Medtronic Sofamor Danek
Orthopedic · 344d
Cleared Dec 10, 2002
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X
K020085 · MNH
Sintea Biotech, Inc.
Orthopedic · 334d
Cleared Dec 10, 2002
THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION,...
K022377 · KWT
Implex Corp.
Orthopedic · 141d
Cleared Dec 10, 2002
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
K023786 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Dec 09, 2002
AAP CANNULATED SCREWS
K021233 · HWC
Aap Implantate AG
Orthopedic · 235d
Cleared Dec 06, 2002
SPECTRUM CERVICAL SPINAL SYSTEM
K022997 · KWQ
Spinal Innovations, LLC
Orthopedic · 88d
Cleared Dec 05, 2002
ASCENDENT ACETABULAR SYSTEM
K022985 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 87d
Cleared Dec 05, 2002
DISTAL RADIUS FRACTURE REPAIR SYSTEM
K023007 · HRS
Hand Innovations, Inc.
Orthopedic · 87d
Cleared Dec 04, 2002
REPIPHYSIS LIMB SALVAGE SYSTEM
K021489 · KRO
Wrightmedicaltechnologyinc
Orthopedic · 210d
Cleared Dec 04, 2002
INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND...
K022048 · KWP
Interpore Cross Intl.
Orthopedic · 163d
Cleared Dec 02, 2002
WRIST IMPLANT
K021859 · JWJ
Avanta Orthopaedics, Inc.
Orthopedic · 179d
Cleared Dec 02, 2002
MODULAR HEAD BONE SCREW
K022952 · HWC
Biomet, Inc.
Orthopedic · 88d
Cleared Dec 02, 2002
KSEA SPINOSCOPE
K023187 · HRX
Karl Storz Endoscopy
Orthopedic · 69d
Cleared Nov 27, 2002
MODIFICATION TO RADIAL HEAD IMPLANT
K023604 · KWI
Avanta Orthopaedics, Inc.
Orthopedic · 30d
Cleared Nov 27, 2002
CADENCE PEEK CEMEENT RESTRICTOR
K023647 · JDK
Spinal Concepts, Inc.
Orthopedic · 28d
Cleared Nov 26, 2002
CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
K013072 · MQV
Synthes
Orthopedic · 439d
Cleared Nov 26, 2002
INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM
K022887 · KWH
Osteomed Corp.
Orthopedic · 88d