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"
73–96 of 270
Search insights Median review: 91d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared Dec 08, 2021
ShurFit Lumbar Interbody System
K212075 · MAX
Precision Spine, Inc.
Orthopedic · 159d
Cleared Nov 05, 2021
Cervical Stand-Alone System
K212853 · OVE
Eminent Spine, LLC
Orthopedic · 59d
Cleared Nov 04, 2021
Dakota ALIF Plate System
K212937 · KWQ
Precision Spine, Inc.
Orthopedic · 50d
Cleared Nov 01, 2021
DePuy CONDUIT LLIF Angled Inserters
K212823 · MAX
Enztec Limited
Orthopedic · 59d
Cleared Oct 13, 2021
CoreLink Navigation Instruments
K212825 · OLO
Corelink, LLC
Orthopedic · 40d
Cleared Sep 29, 2021
DualX
K211740 · MAX
Amplify Surgical, Inc.
Orthopedic · 114d
Cleared Sep 07, 2021
OneLIF Intervertebral Body Replacement System
K211769 · OVD
Novapproach Spine
Orthopedic · 91d
Cleared Aug 30, 2021
KMTI S141 Lumbar Interbody Fusion System
K212070 · MAX
Kyocera Medical Technologies, Inc.
Orthopedic · 59d
Cleared Aug 12, 2021
VERTICALE Navigation Instruments
K212007 · OLO
Silony Medical GmbH
Orthopedic · 45d
Cleared Aug 03, 2021
Cannulated Fasteners and Nuts
K211290 · HWC
OsteoCentric Technologies
Orthopedic · 97d
Cleared Jul 21, 2021
CHIRAVAC Blood Collection Needles
K201009 · JKA
Chirana T. Injecta
General Hospital · 460d
Cleared Apr 30, 2021
OsteoCentric Integrated Hip Fastener System
K210247 · JDO
Osteocentric Technologies D.B.A....
Orthopedic · 91d
Cleared Apr 29, 2021
Expandable Titanium PLIF/TLIF System
K201024 · MAX
Spectrum Spine, LLC
Orthopedic · 374d
Cleared Apr 15, 2021
CoreLink Midline Fixation System
K210539 · NKB
Corelink, LLC
Orthopedic · 50d
Cleared Apr 14, 2021
Cannulated Fasteners and Nuts
K210754 · HWC
OsteoCentric Technologies
Orthopedic · 30d
Cleared Mar 23, 2021
Harvester SI: Sacroiliac Fixation System
K203780 · OUR
Spinus International, Inc.
Orthopedic · 85d
Cleared Mar 02, 2021
Able Medical Devices Valkyrie Thoracic Fixation System
K202889 · HRS
Jm Longyear Manufacturing, LLC D.B.A....
Orthopedic · 155d
Cleared Feb 16, 2021
ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System,...
K210035 · OUR
Aegis Spine
Orthopedic · 41d
Cleared Feb 03, 2021
UNiTi ACDF Implant System
K200301 · PHQ
Pressio, Inc.
Orthopedic · 363d
Cleared Jan 29, 2021
XYPAN Expandable Lumbar Cage System
K203531 · MAX
Aegis Spine, Inc.
Orthopedic · 58d
Cleared Jan 12, 2021
NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System
K203129 · OVE
Precision Spine, Inc.
Orthopedic · 85d
Cleared Dec 28, 2020
Tailored-C Cervical Interbody Fusion System
K200458 · ODP
Bespoke Technologies
Orthopedic · 307d
Cleared Dec 23, 2020
F3D Corpectomy System
K202637 · MQP
Corelink, LLC
Orthopedic · 103d
Cleared Dec 22, 2020
Australis Anterior Lumbar Cage System
K202820 · MAX
Prism Surgical Designs Pty, Ltd.
Orthopedic · 89d