Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

270 results for "Empi"
169–192 of 270
Search insights Median review: 91d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared Jul 07, 2016
CorticaLINK Spinal Fusion Platform
K160722 · NKB
Facetlink Dba Linkspine
Orthopedic · 113d
Cleared Jun 28, 2016
Gibralt® Spine System and Gibralt® Occipital Spine System
K160697 · NKG
Exactech, Inc.
Orthopedic · 106d
Cleared Apr 13, 2016
Diplomat® Spinal System
K151704 · NKB
Signus Medizintechnik GmbH
Orthopedic · 294d
Cleared Mar 28, 2016
SMV Scientific Schanz Screws
K160603 · HWC
Smv Scientific
Orthopedic · 26d
Cleared Mar 09, 2016
S-Wire
K152662 · HTY
Spinal Resources, Inc.
Orthopedic · 174d
Cleared Mar 02, 2016
Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System
K160020 · MNH
Captiva Spine
Orthopedic · 57d
Cleared Feb 04, 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237 · OUR
Corelink, LLC
Orthopedic · 178d
Cleared Jan 19, 2016
Unison-C Anterior Cervical Fixation System
K152793 · OVE
Pioneer Surgical Technology, Inc....
Orthopedic · 113d
Cleared Nov 25, 2015
SMV Scientific Bone Plate and Screw System
K152000 · HRS
Smv Scientific
Orthopedic · 128d
Cleared Aug 07, 2015
Precision Spine Interspinous Plate System
K151863 · PEK
Precision Spine, Inc.
Orthopedic · 30d
Cleared Jul 17, 2015
A-CIFT SoloFuse
K151198 · OVE
Spinefrontier, Inc.
Orthopedic · 73d
Cleared Jul 07, 2015
Reform Pedicle Screw System
K150856 · NKB
Precision Spine, Inc.
Orthopedic · 98d
Cleared Jun 26, 2015
CapLOX II/TowerLOX Pedicle Screw System
K151116 · MNH
Captiva Spine
Orthopedic · 60d
Cleared Jun 04, 2015
Sure Lok Mini Posterior Cervical/Upper Thoracic System
K150851 · KWP
Precision Spine, Inc.
Orthopedic · 65d
Cleared May 28, 2015
Ascendant TM Cervical Spacer System
K150130 · ODP
Exactech, Inc.
Orthopedic · 127d
Cleared May 13, 2015
SpineFrontier Lumbar Interbody Fusion Device System
K142504 · MAX
Spinefrontier, Inc.
Orthopedic · 250d
Cleared May 11, 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · MAX
Exactech, Inc.
Orthopedic · 108d
Cleared Apr 29, 2015
SMV Scientific 4.5 mm Bone Screws
K150188 · HWC
Summit Medventures
Orthopedic · 92d
Cleared Apr 24, 2015
SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System
K150017 · OUR
Spinefrontier, Inc.
Orthopedic · 109d
Cleared Apr 08, 2015
Polyscrew Pedicle Screw System
K150647 · MNI
New Era Orthopedics, LLC
Orthopedic · 27d
Cleared Apr 02, 2015
Reliance Interspinous Plate System
K142217 · PEK
Reliance Medical Systems, LLC
Orthopedic · 233d
Cleared Mar 30, 2015
Eminent Foot Plate System
K143365 · HRS
Eminent Spine
Orthopedic · 126d
Cleared Feb 27, 2015
Exactech Ambassador
K143576 · KWQ
Exactech, Inc.
Orthopedic · 72d
Cleared Feb 25, 2015
Palladian Lumbar Pedicle Screw System
K143230 · NKB
Neurostructures, Inc.
Orthopedic · 107d