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
12121–12144 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 20, 2002
MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
K024060 · HWC
Howmedica Osteonics Corp.
Orthopedic · 11d
Cleared Dec 19, 2002
REFLECTION CONSTRAINED LINER
K021803 · KWZ
Smith & Nephew, Inc.
Orthopedic · 199d
Cleared Dec 19, 2002
NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER
K023862 · MQV
Synthes (Usa)
Orthopedic · 29d
Cleared Dec 18, 2002
ACE VERSANAIL
K023115 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Dec 18, 2002
BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B
K023119 · HTN
Arthrex, Inc.
Orthopedic · 90d
Cleared Dec 16, 2002
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
K023087 · KRO
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 13, 2002
COMPREHENSIVE HUMERAL FRACTURE SYSTEM
K023063 · KWT
Biomet Orthopedics, Inc.
Orthopedic · 88d
Cleared Dec 13, 2002
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
K023415 · KWP
Medtronic Sofamor Danek
Orthopedic · 63d
Cleared Dec 13, 2002
COLUMBUS (CR) TOTAL KNEE SYSTEM
K023788 · JWH
Aesculap, Inc.
Orthopedic · 30d
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