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
5521–5544 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 17, 2015
Klassic Knee System
K153310 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 30d
Cleared Dec 17, 2015
WASTON Metallic Intramedullary Nail System
K151062 · HSB
Changzhou Waston Medical Appliance...
Orthopedic · 241d
Cleared Dec 15, 2015
AccuLIF TL and PL Cage
K152651 · MAX
Stryker Corporation
Orthopedic · 90d
Cleared Dec 15, 2015
Remedy® Shoulder Spacer
K152267 · KWS
Osteoremedies, LLC
Orthopedic · 126d
Cleared Dec 15, 2015
Latitude-C Cervical Interbody Spacer System
K151496 · ODP
Degen Medical
Orthopedic · 195d
Cleared Dec 14, 2015
Endoskeleton(r) TCS System
K153122 · OVE
Titan Spine, LLC
Orthopedic · 46d
Cleared Dec 14, 2015
Cardinal Health Trochanteric IM Nail System
K150769 · HSB
Cardinalhealth
Orthopedic · 265d
Cleared Dec 14, 2015
V-STEADY, V-FAST
K150408 · LOD
G21, S.R.L.
Orthopedic · 299d
Cleared Dec 11, 2015
SpeedLock Knotless Fixation System
K153313 · MBI
ArthroCare Corporation
Orthopedic · 24d
Cleared Dec 11, 2015
Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System
K152987 · ODP
Xenco Medical, LLC
Orthopedic · 59d
Cleared Dec 11, 2015
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Dec 11, 2015
MotoBand¿ CP Implant System
K152306 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 119d
Cleared Dec 11, 2015
VariLift-L Interbody Fusion Device
K151900 · MAX
Wenzel Spine, Inc.
Orthopedic · 154d
Cleared Dec 11, 2015
FIREFLY Pedicle Screw Navigation Guide
K143222 · MNI
Mighty Oak Medical, Inc.
Orthopedic · 396d
Cleared Dec 11, 2015
Spinal Inner Fixation System
K143013 · MNH
Changzhou Dingjian Medical Appliance...
Orthopedic · 417d
Cleared Dec 10, 2015
AOS Small Fragment Plating System
K152732 · HRS
Avanced Orthopaedic Solutions, Inc....
Orthopedic · 79d
Cleared Dec 10, 2015
Twin Peaks Lumbar Interbody Fusion System
K152355 · MAX
Spineway
Orthopedic · 112d
Cleared Dec 07, 2015
ROI-C Titanium-Coated Implant System
K151934 · OVE
Ldr Spine USA
Orthopedic · 146d
Cleared Dec 04, 2015
FastFrame External Fixation System - Distal Radius
K152484 · KTT
Zimmer, Inc.
Orthopedic · 95d
Cleared Dec 02, 2015
XIA 4.5 Spinal Fixation System, Power Adaaptor Instrument Accessory
K152632 · NKB
Stryker Corporation
Orthopedic · 78d
Cleared Dec 02, 2015
PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01,...
K152566 · MBI
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Dec 02, 2015
Zero-P Natural Plate System
K152239 · KWQ
Synthes (Usa), LLC
Orthopedic · 114d
Cleared Dec 01, 2015
NuVasive Foundation-LL System
K152943 · OVD
Nu Vasive, Incorporated
Orthopedic · 57d
Cleared Dec 01, 2015
PCT System
K152211 · NKG
Centinel Spine, Inc.
Orthopedic · 116d