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
11665–11688 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 20, 2004
HANSSON PIN SYSTEM
K033968 · HTY
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared Feb 20, 2004
OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS
K040199 · JDQ
Osseus, LLC
Orthopedic · 22d
Cleared Feb 20, 2004
TRIGEN INTERTAN
K040212 · JDS
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Feb 18, 2004
CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT
K031859 · KWD
Arthrosurface, Inc.
Orthopedic · 247d
Cleared Feb 18, 2004
SPINAL CONCEPTS INC. CADENCE AND TRAXIS
K033517 · MQP
Spinal Concepts, Inc.
Orthopedic · 103d
Cleared Feb 18, 2004
VERTE-STACK SPINAL SYSTEM
K040167 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Feb 13, 2004
EIUS UNICOMPARTMENTAL KNEE SYSTEM
K033769 · HSX
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Feb 13, 2004
TITANIUM TOGGLE BUTTON(S)
K033838 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 65d
Cleared Feb 13, 2004
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED...
K033883 · JWH
Exactech, Inc.
Orthopedic · 60d
Cleared Feb 12, 2004
TITANIUM MESH SYSTEM
K032371 · MQP
Encore Medical, L.P.
Orthopedic · 195d
Cleared Feb 12, 2004
PRECISION SURGERY LIMITED VARIABLE AND FIXED CERVICAL PLATE SYSTEM
K032815 · KWQ
Precision Surgery Limited
Orthopedic · 156d
Cleared Feb 12, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Feb 11, 2004
LINVATEC 10K IRRIGATION SYSTEM
K033573 · HRX
Linvatec Corp.
Orthopedic · 90d
Cleared Feb 11, 2004
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
K040034 · MNI
Blackstone Medical, Inc.
Orthopedic · 34d
Cleared Feb 06, 2004
VOLAR RADIUS PLATE WITH ANGULAR STABILITY
K033756 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 67d
Cleared Feb 05, 2004
TRIMED RADIAL BULLET
K030877 · HRS
Tri-Med, Inc.
Orthopedic · 322d
Cleared Feb 05, 2004
DEPUY SIGMA TIBIAL INSERTS
K033272 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 118d
Cleared Feb 05, 2004
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K033382 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 105d
Cleared Feb 05, 2004
SMARTSET GHV GENTAMICIN BONE CEMENT
K033563 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Feb 05, 2004
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
K033618 · HSB
Synthes (Usa)
Orthopedic · 79d
Cleared Feb 05, 2004
SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
K033844 · KWQ
Synthes (Usa)
Orthopedic · 56d
Cleared Feb 02, 2004
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
K033506 · KWS
Biomet, Inc.
Orthopedic · 89d
Cleared Jan 28, 2004
EVOLVE RADIAL PLATE
K033456 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jan 28, 2004
SKY BONE EXPANDER SYSTEM
K034037 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d