FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
5809–5832 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 12, 2015
Iliad Pedicle Screw System and Zenius Pedicle Screw System
K142835 · NKB
Medyssey USA, Inc.
Orthopedic · 255d
Cleared Jun 11, 2015
NuVasive CoRoent Small Interbody System
K150362 · ODP
Nu Vasive, Incorporated
Orthopedic · 119d
Cleared Jun 11, 2015
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K150135 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 141d
Cleared Jun 11, 2015
Avenue T TLIF Cage
K142645 · OVD
Ldr Spine USA, Inc.
Orthopedic · 267d
Cleared Jun 11, 2015
Captiva Spine SmartLOX Cervical Plate System
K141332 · KWQ
Captiva Spine
Orthopedic · 386d
Cleared Jun 10, 2015
Affixus Tibial Nailing System
K150867 · HSB
Biomet, Inc.
Orthopedic · 70d
Cleared Jun 10, 2015
Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space...
K143572 · ODP
Osteomed Implantes, Ltda
Orthopedic · 175d
Cleared Jun 09, 2015
OASYS System
K150753 · KWP
Stryker Corporation
Orthopedic · 78d
Cleared Jun 09, 2015
APTUS Wrist 2.5 System
K142906 · HRS
Medartis AG
Orthopedic · 246d
Cleared Jun 09, 2015
ELEVATE Spinal System
K142559 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 271d
Cleared Jun 09, 2015
Reliance Cervical IBF System
K142269 · ODP
Reliance Medical Systems, LLC
Orthopedic · 298d
Cleared Jun 08, 2015
Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
K150643 · OVD
Centinel Spine, Inc.
Orthopedic · 88d
Cleared Jun 05, 2015
DPZ Pedicular Fixation System
K150294 · MNI
Osteomed Implantes, Ltda
Orthopedic · 119d
Cleared Jun 05, 2015
Metallic Locking Bone Plate and Screw System
K143002 · HRS
Changzhou Dingjian Medical Appliance...
Orthopedic · 228d
Cleared Jun 04, 2015
Sure Lok Mini Posterior Cervical/Upper Thoracic System
K150851 · KWP
Precision Spine, Inc.
Orthopedic · 65d
Cleared Jun 04, 2015
Tritium Sternal Cable Plate System
K150581 · JDQ
Pioneer Surgical Technology, Inc....
Orthopedic · 87d
Cleared Jun 04, 2015
ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS
K150552 · NKG
Globus Medical, Inc.
Orthopedic · 92d
Cleared Jun 04, 2015
ToeTac Hammertoe Fixation System
K150443 · HWC
Restore Surgical, LLC Dba Instratek
Orthopedic · 104d
Cleared Jun 03, 2015
Mercury Spinal System
K151215 · NKB
Spinal Elements, Inc.
Orthopedic · 28d
Cleared Jun 03, 2015
ANAX OCT Spinal System
K150570 · NKG
U&I Corporation
Orthopedic · 89d
Cleared Jun 03, 2015
AOS Clavicle Intramedullary Device
K143204 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 208d
Cleared May 29, 2015
Exactech Optetrak Logic CC
K150890 · JWH
Exactech, Inc.
Orthopedic · 57d
Cleared May 29, 2015
MAGEC 2 Spinal Bracing and Distraction System
K150885 · PGN
Ellipse Technologies, Incorporated
Orthopedic · 57d
Cleared May 29, 2015
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
K150544 · JWH
Aesculap Implant Systems, LLC
Orthopedic · 87d