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
5761–5784 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 14, 2015
Nautilus Spinal System
K151196 · NKB
Life Spine, Inc.
Orthopedic · 70d
Cleared Jul 14, 2015
InFill Interbody Fusion Devices
K151184 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 71d
Cleared Jul 14, 2015
Pyrenees Cervical Plate System
K150983 · KWQ
K2m
Orthopedic · 91d
Cleared Jul 13, 2015
EVOS Lumbar Interbody System
K150321 · MAX
Cutting Edge Spine, LLC
Orthopedic · 154d
Cleared Jul 10, 2015
Atrax Anterior Cervical Plating System
K150834 · KWQ
X-Spine Systems, Inc.
Orthopedic · 102d
Cleared Jul 10, 2015
The Simple Locking IntraMedullary (SLIM) System
K143355 · HSB
Pega Medical, Inc.
Orthopedic · 228d
Cleared Jul 10, 2015
SpineFab Vertebral Body Replacement (VBR) System
K142005 · MQP
Oxford Performance Materials
Orthopedic · 352d
Cleared Jul 09, 2015
OASYS(r) System
K151755 · NKG
Stryker Corporation
Orthopedic · 10d
Cleared Jul 09, 2015
Leva Spacer System
K151581 · MAX
Spine Wave, Inc.
Orthopedic · 28d
Cleared Jul 09, 2015
EndoLIF On-Cage
K151143 · MAX
Joimax GmbH
Orthopedic · 71d
Cleared Jul 09, 2015
GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle
K151037 · MBI
Conmed Corporation
Orthopedic · 80d
Cleared Jul 09, 2015
OIC Intramedullary Nail System
K150655 · HSB
Orthopaedic Implant Company
Orthopedic · 118d
Cleared Jul 09, 2015
BONGOLD BONE GRAFT MATERIAL
K141725 · MQV
Beijing Allgens Medical Science &...
Orthopedic · 378d
Cleared Jul 07, 2015
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
K151488 · NKB
Orthofix, Inc.
Orthopedic · 35d
Cleared Jul 07, 2015
Reform Pedicle Screw System
K150856 · NKB
Precision Spine, Inc.
Orthopedic · 98d
Cleared Jul 07, 2015
ST.A.R. 90 F4 External Fixation Screws With Hydroxyapatite
K150661 · JDW
Citieffe S.R.L.
Orthopedic · 116d
Cleared Jul 02, 2015
Arthrex Corkscrew and SwiveLock Suture Anchors
K143745 · MBI
Arthrex, Inc.
Orthopedic · 183d
Cleared Jul 01, 2015
Suture Wires and Wire Loops
K150889 · JDQ
Zimmer, Inc.
Orthopedic · 90d
Cleared Jul 01, 2015
ASFORA ANTERIOR CERVICAL PLATE SYSTEM
K143688 · KWQ
Medical Designs, LLC
Orthopedic · 189d
Cleared Jul 01, 2015
CastleLoc-P Anterior Cervical Plate System
K143271 · KWQ
L & K Biomed Co., Ltd.
Orthopedic · 230d
Cleared Jun 30, 2015
Lineum OCT Spine System
K151224 · NKG
Biomet Spine
Orthopedic · 54d
Cleared Jun 30, 2015
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate...
K141680 · HRS
Auxein Medical
Orthopedic · 372d
Cleared Jun 29, 2015
Stryker ICONIX with Needles
K151201 · MBI
Stryker
Orthopedic · 55d
Cleared Jun 26, 2015
CapLOX II/TowerLOX Pedicle Screw System
K151116 · MNH
Captiva Spine
Orthopedic · 60d