FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

Filters: Orthopedic ×
17,985 results
3265–3288 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 03, 2020
AltiVate Anatomic Canal-Sparing (CS) Shoulder
K193226 · PKC
Encore Medical, L.P.
Orthopedic · 194d
Cleared Jun 02, 2020
Altus Spine Pedicle Screw System
K200322 · NKB
Altus Partners, LLC
Orthopedic · 113d
Cleared Jun 02, 2020
HIP7
K193307 · OLO
Brainlab AG
Orthopedic · 186d
Cleared Jun 01, 2020
Skeletal Dynamics Forearm Plating System
K200538 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 90d
Cleared May 29, 2020
Stealthstation S8 Spine Software v1.3.0
K201189 · OLO
Medtronic Navigation, Inc.
Orthopedic · 28d
Cleared May 29, 2020
Idys ALIF ZP 3DTi
K200920 · MAX
Clariance, Sas
Orthopedic · 53d
Cleared May 29, 2020
KONG-TL VBR System, KONG-C VBR System
K200235 · MQP
Icotec AG
Orthopedic · 120d
Cleared May 29, 2020
Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device
K200002 · OVD
4Web, Inc.
Orthopedic · 148d
Cleared May 28, 2020
Meridian Anterior Plate System, Regatta Lateral Plate System
K200885 · KWQ
SeaSpine Orthopedics Corporation
Orthopedic · 56d
Cleared May 27, 2020
Restoration® Modular Hip System
K193233 · LPH
Howmedica Osteonics Corp. (Aka...
Orthopedic · 184d
Cleared May 27, 2020
Joline Kyphoplasty System Allevo
K192449 · NDN
Joline GmbH & Co. KG
Orthopedic · 264d
Cleared May 22, 2020
Invictus™ CT Spinal Fixation System
K200936 · NKG
Alphatec Spine, Inc.
Orthopedic · 44d
Cleared May 22, 2020
JPS JuniOrtho Plating System
K200246 · HRS
Orthofix Srl
Orthopedic · 112d
Cleared May 22, 2020
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
K193423 · NKB
Icotec AG
Orthopedic · 165d
Cleared May 21, 2020
Insignia™ Anterior Cervical Plate System
K200995 · KWQ
Alphatec Spine, Inc.
Orthopedic · 35d
Cleared May 21, 2020
NEXXT MATRIXX System
K200969 · MAX
Nexxt Spine, LLC
Orthopedic · 38d
Cleared May 21, 2020
NuVasive Thoracolumbar Plates
K200956 · KWQ
Nu Vasive, Incorporated
Orthopedic · 42d
Cleared May 20, 2020
NuVasive® ACP System
K201078 · KWQ
Nu Vasive, Incorporated
Orthopedic · 28d
Cleared May 20, 2020
Axis Spine Technologies ALIF
K200352 · OVD
Axis Spine Technologies, Ltd.
Orthopedic · 97d
Cleared May 19, 2020
Reform Pedicle Screw System
K200303 · NKB
Precision Spine
Orthopedic · 103d
Cleared May 18, 2020
MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto...
K191906 · MAX
MiRus, LLC
Orthopedic · 307d
Cleared May 15, 2020
Biocore9 Humeral Resurfacing System
K193122 · HSD
Biocore9, LLC
Orthopedic · 185d
Cleared May 14, 2020
Skeletal Dynamics Midshaft Humerus Plating System
K200701 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 57d
Cleared May 14, 2020
Distal Humerus Plating System
K200367 · HRS
Skeletal Dynamics, Inc.
Orthopedic · 90d