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"
145–168 of 270
Search insights Median review: 91d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared Feb 26, 2018
Neurostructures Cavetto® Cervical Cage System
K172320 · ODP
Neurostructures, Inc.
Orthopedic · 209d
Cleared Feb 23, 2018
Cavetto-SA Cervical Cage System
K173077 · OVE
Neurostructures, Inc.
Orthopedic · 147d
Cleared Dec 19, 2017
Reform® Midline Cortical Screw System
K173130 · NKB
Precision Spine, Inc.
Orthopedic · 81d
Cleared Dec 14, 2017
InFill® Interbody Fusion Device
K172349 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 133d
Cleared Oct 25, 2017
Cortina™ Lumbar Cage System
K171914 · MAX
Neurostructures, Inc.
Orthopedic · 121d
Cleared Oct 23, 2017
Acapella Cervical Spacer System
K171489 · OVE
Choicespine, LP
Orthopedic · 154d
Cleared Sep 15, 2017
FLXfit™
K171519 · MAX
Expanding Orthopedics, Inc.
Orthopedic · 114d
Cleared Jul 13, 2017
HD Lumbar Interbody System
K170676 · MAX
Hd Lifesciences, LLC
Orthopedic · 129d
Cleared Jun 29, 2017
PHA S1 Spinal System
K163011 · NKB
Phamedica, Inc.
Orthopedic · 244d
Cleared Jun 26, 2017
Swedge™ Pedicle Screw Fixation System
K170045 · NKB
Spinal Resources, Inc.
Orthopedic · 172d
Cleared Jun 21, 2017
Terrace™ Anterior Cervical Plate System
K163104 · KWQ
Corelink, LLC
Orthopedic · 226d
Cleared Jun 08, 2017
Trifore(tm) Cervical Plating System
K171112 · KWQ
Neurostructures, Inc.
Orthopedic · 55d
Cleared May 22, 2017
SMV Scientific Cannulated Screws
K170021 · HWC
Smv Scientific
Orthopedic · 139d
Cleared May 04, 2017
Foundation 3D Interbody
K162496 · ODP
Corelink, LLC
Orthopedic · 239d
Cleared May 02, 2017
Xultan 5.5 Pedicle Screw System
K170108 · NKB
Met One Technologies
Orthopedic · 110d
Cleared Mar 10, 2017
CAVUX CervicalCage-L SA System
K163474 · OVE
Providence Medical Technology, Inc.
Orthopedic · 88d
Cleared Feb 09, 2017
Atlas Spine Expandable Interbody System
K162918 · MAX
Atlas Spine, Inc.
Orthopedic · 114d
Cleared Dec 05, 2016
4.0 and 6.5 Cancellous Bone Screw and Washer
K160946 · HWC
Smv Scientific
Orthopedic · 244d
Cleared Nov 28, 2016
AccuFit Lateral Plate System
K162211 · KWQ
Precision Spine, Inc.
Orthopedic · 112d
Cleared Nov 23, 2016
Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture,
K160705 · NEW
Y. Jacobs Medical, Inc.
General & Plastic Surgery · 254d
Cleared Nov 22, 2016
Reform® POCT System
K162300 · NKG
Precision Spine, Inc.
Orthopedic · 98d
Cleared Nov 09, 2016
Virtu C Spinal Implant System
K161649 · ODP
Met 1 Technologies, LLC
Orthopedic · 147d
Cleared Aug 01, 2016
VIRTU Lumbar Spacer System
K160699 · MAX
Met 1 Technologies, LLC
Orthopedic · 140d
Cleared Jul 15, 2016
Belvedere™ Lateral Plating System
K153097 · KWQ
Neurostructures, Inc.
Orthopedic · 263d