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
5665–5688 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 10, 2016
Anterior Cervical Plate System
K151553 · KWQ
Osteomed Implantes, Ltda
Orthopedic · 246d
Cleared Feb 09, 2016
Epic Extremity Plate System
K153340 · HRS
Epic Extremity, LLC
Orthopedic · 82d
Cleared Feb 05, 2016
MINIARS SCREWS
K143596 · HWC
Overmed Srl.
Orthopedic · 414d
Cleared Feb 04, 2016
Rampart A Lumbar Interbody Fusion Device
K153082 · MAX
Spineology, Inc.
Orthopedic · 104d
Cleared Feb 04, 2016
The Entasis Dual-Lead Sacroiliac Implant
K152237 · OUR
Corelink, LLC
Orthopedic · 178d
Cleared Feb 03, 2016
Comprehensive SRS/Nexel Elbow
K153398 · JDC
Biomet Manufacturing Corp
Orthopedic · 71d
Cleared Feb 03, 2016
Navigation Instruments
K153203 · OLO
Globus Medical, Inc.
Orthopedic · 91d
Cleared Feb 02, 2016
M-Fix Acromioclavicular Device
K153211 · HTN
Coracoid Solutions, Inc.
Orthopedic · 89d
Cleared Feb 01, 2016
In2Bones Kirschner wire
K153204 · HTY
In2bones Sas
Orthopedic · 89d
Cleared Feb 01, 2016
YAHUA Spinal System
K152324 · MNI
Beijing Weigao Yahua Artificial Joint...
Orthopedic · 168d
Cleared Jan 29, 2016
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System
K153428 · NKB
Orthofix, Inc.
Orthopedic · 65d
Cleared Jan 29, 2016
PASS OCT Patient Specific Rods
K153169 · NKG
Medicrea International
Orthopedic · 88d
Cleared Jan 29, 2016
COALITION Spacers
K151939 · OVE
Globus Medical, Inc.
Orthopedic · 199d
Cleared Jan 29, 2016
TriMed Humeral Supracondylar Fixation System
K151735 · HRS
TriMed, Inc.
Orthopedic · 217d
Cleared Jan 28, 2016
Seneka II Polyscrew Pedicle Fixation System
K153525 · NKB
Senecka Spine
Orthopedic · 50d
Cleared Jan 28, 2016
Adjustable Fixation Device
K153186 · MBI
Arthrocare Corp.
Orthopedic · 86d
Cleared Jan 28, 2016
dynaMX Tabbed Staple
K153129 · JDR
Mx Orthopedics, Corp.
Orthopedic · 90d
Cleared Jan 28, 2016
Half Dome Posterior Lumbar Interbody System
K152512 · MAX
Astura Medical
Orthopedic · 148d
Cleared Jan 28, 2016
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
K151716 · HRS
Zimmer, Inc.
Orthopedic · 217d
Cleared Jan 26, 2016
Tenodesis screw system
K151701 · HWC
Normed Medizin-Technik GmbH
Orthopedic · 216d
Cleared Jan 25, 2016
Perla Posterior Cervico-Thoracic Fixation system
K153386 · NKG
Spineart
Orthopedic · 63d
Cleared Jan 25, 2016
FacetBRIDGE System
K152137 · MRW
Ldr Spine USA
Orthopedic · 178d
Cleared Jan 21, 2016
Release Laminoplasty Fixation System
K153735 · NQW
Pioneer Surgical Technology, Inc....
Orthopedic · 24d
Cleared Jan 21, 2016
Biomet Spine Fusion System
K153695 · MAX
Biomet Spine, LLC
Orthopedic · 29d