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"
97–120 of 270
Search insights Median review: 91d Cleared: 100% Top manufacturer: Empi Lead specialty: Orthopedic
Cleared Dec 08, 2020
Accu-Joint Hemi Implant
K200951 · KWD
Accufix Surgical, Inc.
Orthopedic · 243d
Cleared Dec 03, 2020
LineSider™ Spinal System
K203367 · NKB
Integrity Implants, Inc.
Orthopedic · 17d
Cleared Dec 03, 2020
aprevo Intervertebral Body Fusion Device
K202034 · MAX
Carlsmed, Inc.
Orthopedic · 133d
Cleared Oct 26, 2020
ACURA Stabilization System
K200937 · NKB
Indius Medical Technologies Pvt. , Ltd.
Orthopedic · 201d
Cleared Oct 08, 2020
GAIA Lumbar Interbody Fusion Device (LIFD) Family
K201939 · MAX
Printerprezz
Orthopedic · 87d
Cleared Oct 02, 2020
Oculus-SA Lumbar Cage System
K202190 · OVD
Neurostructures
Orthopedic · 58d
Cleared Sep 24, 2020
Cavetto-SA Cervical Cage System
K200115 · OVE
Neurostructures, Inc.
Orthopedic · 247d
Cleared Sep 03, 2020
Cavetto [MAX] Cervical Cage System
K201769 · ODP
Neurostructures, Inc.
Orthopedic · 66d
Cleared Aug 25, 2020
Cervical Plate System
K201979 · KWQ
Eminent Spine, LLC
Orthopedic · 40d
Cleared Aug 06, 2020
Medina Anterior Cervical Plate System
K201521 · KWQ
Alliance Partners, LLC
Orthopedic · 59d
Cleared Aug 05, 2020
Aurora® Anterior Lumbar Plate Sytstem
K201079 · KWQ
Prism Surgical Design Pty , Ltd.
Orthopedic · 105d
Cleared Jul 24, 2020
Transept Cervical Plate System
K200927 · KWQ
Neurostructures, Inc.
Orthopedic · 108d
Cleared Jun 15, 2020
F3D Cervical Stand-Alone Interbody Fusion System
K200087 · OVE
Corelink, LLC
Orthopedic · 152d
Cleared May 04, 2020
Headless Compression Screw System
K200259 · HWC
Osteocentric Extremities, LLC
Orthopedic · 91d
Cleared Apr 30, 2020
SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices
K200816 · MAX
Spineex, Inc.
Orthopedic · 31d
Cleared Apr 28, 2020
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
K200863 · NKG
Corelink, LLC
Orthopedic · 27d
Cleared Mar 24, 2020
SEA-LINK Anterior Cervical Plate System
K200224 · KWQ
Indius Medical Technologies Pvt. , Ltd.
Orthopedic · 55d
Cleared Mar 06, 2020
MEGAFIX® Pedicle Screw Spinal System
K191655 · NKB
Seohancare Co., Ltd.
Orthopedic · 259d
Cleared Feb 13, 2020
OrthoCircle Spine Pedicle Screw System
K193472 · NKB
Orthocircle Spine
Orthopedic · 59d
Cleared Nov 25, 2019
Cortina™ [MAX] Lumbar Cage System
K192248 · MAX
Neurostructures, Inc.
Orthopedic · 98d
Cleared Oct 15, 2019
DualX Lumbar Intervertebral Body Fusion Device
K192434 · MAX
Amplify Surgical, Inc.
Orthopedic · 40d
Cleared Sep 27, 2019
Precision Spine Navigation Instrumentation
K181606 · OLO
Precision Spine, Inc.
Orthopedic · 465d
Cleared Jun 21, 2019
LineSider™ Spinal System
K190360 · NKB
Integrity Implants, Inc.
Orthopedic · 126d
Cleared Jun 13, 2019
Oyster ACIF Cage
K182608 · ODP
Silony Medical GmbH
Orthopedic · 265d