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
12649–12672 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 25, 2002
FINGER JOINT PROSTHESIS
K013629 · KYJ
Avanta Orthopaedics, Inc.
Orthopedic · 81d
Cleared Jan 25, 2002
T2 FEMORAL NAIL SYSTEM
K014220 · HSB
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 25, 2002
UNITRAX MODULAR UNIPOLAR SYSTEM
K014226 · KWL
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 25, 2002
MODIFICATION TO OPUS SPINAL SYSTEM
K014229 · MNH
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jan 25, 2002
BUTTERFLY PLATE FIXATION SYSTEM
K014267 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jan 23, 2002
BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW
K013558 · KWQ
Blackstone Medical, Inc.
Orthopedic · 90d
Cleared Jan 18, 2002
PLLA CANNULATED INTERFERENCE SCREW
K013685 · HWC
Future Medical Systems, Inc.
Orthopedic · 72d
Cleared Jan 17, 2002
CEMENTED CALCAR HIP SYSTEM
K013490 · LPH
Encore Orthopedics, Inc.
Orthopedic · 87d
Cleared Jan 17, 2002
DEKOMPRESSOR PERCUTANEOUS LUMBAR DISCECTOMY PROBE
K013513 · HRX
Pain Concepts, Inc.
Orthopedic · 87d
Cleared Jan 17, 2002
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM,...
K014145 · MQP
Interpore Cross Intl.
Orthopedic · 30d
Cleared Jan 17, 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K014194 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Jan 16, 2002
MODIFICATION TO EBI OMEGA 21 SYSTEM
K014137 · MNH
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 15, 2002
PASS SPINAL SYSTEM
K013442 · KWP
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 15, 2002
ISOBAR SPINAL SYSTEM
K013447 · KWP
Scien'Tx USA, Inc.
Orthopedic · 90d
Cleared Jan 14, 2002
ANTERIOR CERVICAL PLATE SYSTEM
K013439 · KWQ
Scien'Tx USA, Inc.
Orthopedic · 89d
Cleared Jan 11, 2002
SYNTHES ANKLE ARTHRODESIS PLATE
K013415 · HRS
Synthes (Usa)
Orthopedic · 88d
Cleared Jan 11, 2002
ACTAEON PROBE
K013429 · NGR
Osteobiologics, Inc.
Orthopedic · 87d
Cleared Jan 09, 2002
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K013385 · KRO
Zimmer, Inc.
Orthopedic · 89d
Cleared Jan 09, 2002
EPOCA CODR STEM AND HEAD
K014049 · KWT
Stelkast Company
Orthopedic · 30d
Cleared Jan 08, 2002
TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM
K013775 · HRS
Stryker Leibinger
Orthopedic · 56d
Cleared Dec 31, 2001
MSI BIPOLAR SHEATH
K011202 · HRX
Medical Scientific, Inc.
Orthopedic · 256d
Cleared Dec 27, 2001
SPINAL MESH SYSTEM
K011406 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 233d
Cleared Dec 27, 2001
AVALON CUP SYSTEM
K011887 · JDI
Orthopedic Source, Inc.
Orthopedic · 192d
Cleared Dec 27, 2001
LONG TROCHANTERIC NAIL SYSTEM
K013563 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 62d