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
11473–11496 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 14, 2004
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE...
K040980 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jul 09, 2004
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
K040281 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 154d
Cleared Jul 09, 2004
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
K041454 · HRX
Kyphon, Inc.
Orthopedic · 38d
Cleared Jul 09, 2004
PROFEMUR S HIP STEM
K041586 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 25d
Cleared Jul 07, 2004
COPSIOS BONE VOID FILLER (BVF)
K033679 · MQV
Centerpulse Spine-Tech, Inc.
Orthopedic · 226d
Cleared Jul 07, 2004
HOURGLASS VERTEBRAL BODY SPACER
K033926 · MQP
Medtronic Sofamor Danek
Orthopedic · 202d
Cleared Jul 07, 2004
KYPHX HV-R BONE CEMENT, MODEL C01A
K041584 · NDN
Kyphon, Inc.
Orthopedic · 23d
Cleared Jul 06, 2004
3DKNEE POROUS COATED FEMORAL COMPONENT
K032905 · MBH
Encore Orthopedics, Inc.
Orthopedic · 293d
Cleared Jul 06, 2004
OPTIMESH 500E CEMENT RESTRICTOR
K033953 · JDK
Spineology, Inc.
Orthopedic · 197d
Cleared Jul 06, 2004
EBI XFIX DFS SYSTEM
K040935 · KTT
Ebi, L.P.
Orthopedic · 88d
Cleared Jul 01, 2004
ORTHOPEDIC ALLIANCE SPINE SYSTEM
K033826 · MNI
Orthopedic Alliance, LLC
Orthopedic · 204d
Cleared Jul 01, 2004
RADIX CERVICAL PLATE
K033951 · KWQ
Pisharodi Surgicals, Inc.
Orthopedic · 192d
Cleared Jul 01, 2004
LPS
K033959 · JWH
Depuy, Inc.
Orthopedic · 192d
Cleared Jul 01, 2004
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM
K040096 · KWP
Spinal Concepts, Inc.
Orthopedic · 163d
Cleared Jul 01, 2004
ARTHREX SMALL FRAGMENT PLATES AND SCREWS
K040907 · HRS
Arthrex, Inc.
Orthopedic · 85d
Cleared Jul 01, 2004
RADIAL NAIL SYSTEM
K040938 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 80d
Cleared Jul 01, 2004
OMEGA 2 SYSTEM
K041001 · KTT
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Jul 01, 2004
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
K041081 · KTT
Hand Innovations, Inc.
Orthopedic · 66d
Cleared Jul 01, 2004
REVISION KNEE SYSTEM
K041106 · JWH
Smith & Nephew, Inc.
Orthopedic · 64d
Cleared Jul 01, 2004
SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION...
K041449 · KWP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jul 01, 2004
CD HORIZON SPINAL SYSTEM
K041460 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jul 01, 2004
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)
K041466 · JWH
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Jul 01, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041556 · MQP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Jul 01, 2004
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE...
K041656 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 13d