FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

253 results for "Empi"
145–168 of 253
Search insights Median review: 90d 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 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 Nov 28, 2016
AccuFit Lateral Plate System
K162211 · KWQ
Precision Spine, Inc.
Orthopedic · 112d
Cleared Nov 22, 2016
Reform® POCT System
K162300 · NKG
Precision Spine, Inc.
Orthopedic · 98d
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 Feb 04, 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237 · OUR
Corelink, LLC
Orthopedic · 178d
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