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
12481–12504 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 15, 2002
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K020196 · MNH
Sulzer Spine-Tech
Orthopedic · 24d
Cleared Feb 14, 2002
MODIFICATION TO PASS SPINAL SYSTEM
K020236 · KWP
Encore Orthopedics, Inc.
Orthopedic · 22d
Cleared Feb 14, 2002
OSTEONICS SPINAL SYSTEM
K020293 · MNH
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Feb 13, 2002
UNI-T SPINAL SYSTEM
K013301 · MNI
Spine Vision, Inc.
Orthopedic · 133d
Cleared Feb 13, 2002
P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
K013312 · KWP
Spine Vision, Inc.
Orthopedic · 132d
Cleared Feb 13, 2002
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
K013979 · KWQ
Spinal Concepts, Inc.
Orthopedic · 72d
Cleared Feb 13, 2002
ENDIUS CERVICAL PLATE SYSTEM
K014107 · KWQ
Endius, Inc.
Orthopedic · 62d
Cleared Feb 13, 2002
AOS CANNULATED BONE SCREW SYSTEM
K014185 · HWC
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 55d
Cleared Feb 12, 2002
BACFIX SPINAL FIXATION SYSTEM
K013887 · MNH
Spinal Concepts, Inc.
Orthopedic · 81d
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