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
12577–12600 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 05, 2001
AUTOGENESIS AUTOMATOR, MODEL M1000
K013818 · JEC
Autogenesis, Inc.
Orthopedic · 19d
Cleared Dec 03, 2001
RESORBABLE NO PROFILE SCREW AND WASHER
K012469 · HWC
Biomet Manufacturing, Inc.
Orthopedic · 123d
Cleared Dec 03, 2001
SOFT TISSUE SCREW AND WASHER
K012572 · HWC
Biomet, Inc.
Orthopedic · 116d
Cleared Dec 03, 2001
SYNTHES 2.4 MM CANNULATED SCREW
K012945 · HWC
Synthes (Usa)
Orthopedic · 90d
Cleared Dec 03, 2001
SYNTHES 3.9 MM PELVIC SCREWS
K013044 · HWC
Synthes (Usa)
Orthopedic · 84d
Cleared Dec 03, 2001
MODIFICATION TO: BIOMET HUMERAL CABLE PLATES
K013657 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 27d
Cleared Dec 03, 2001
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K013772 · LXT
Howmedica Osteonics
Orthopedic · 20d
Cleared Nov 29, 2001
RESECTION ABLATOR
K013117 · HRX
Linvatec Corp.
Orthopedic · 72d
Cleared Nov 27, 2001
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K012516 · KWP
Ebi, L.P.
Orthopedic · 113d
Cleared Nov 27, 2001
FRONTIER ANTERIOR SCOLIOSIS SYSTEM
K012916 · KWQ
Depuy Acromed, Inc.
Orthopedic · 89d
Cleared Nov 27, 2001
APEX MODULAR ALUMINA FEMORAL HEAD
K012918 · LZO
Apex Surgical, LLC
Orthopedic · 89d
Cleared Nov 26, 2001
C3 ANTERIOR CERVICAL PLATE SYSTEM
K012881 · KWQ
Spine Vision, Inc.
Orthopedic · 90d
Cleared Nov 21, 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
K013546 · HWC
Bionx Implants, Inc.
Orthopedic · 28d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
K012817 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
K012818 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Nov 20, 2001
RESORBABLE SCREW ANCHOR
K012872 · HWC
Arthrotek, Inc.
Orthopedic · 85d
Cleared Nov 20, 2001
EBI XFIX ACCESS PELVIC FIXATOR
K013540 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Nov 16, 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · KWQ
Aesculap, Inc.
Orthopedic · 179d
Cleared Nov 16, 2001
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773 · MRW
Depuyacromed
Orthopedic · 88d
Cleared Nov 16, 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776 · JWH
Howmedica Osteonics Corp.
Orthopedic · 88d
Cleared Nov 16, 2001
INTEX SCREW
K012798 · HWC
Biomet, Inc.
Orthopedic · 87d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013440 · MNI
Scien'Tx USA, Inc.
Orthopedic · 30d
Cleared Nov 16, 2001
ISOLA POLYAXIAL WASHER
K013441 · KWP
Depuyacromed
Orthopedic · 30d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013444 · MNH
Scien'Tx USA, Inc.
Orthopedic · 30d