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
5857–5880 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 13, 2015
SpineFrontier Lumbar Interbody Fusion Device System
K142504 · MAX
Spinefrontier, Inc.
Orthopedic · 250d
Cleared May 12, 2015
Dorsal Spanning Plate
K150675 · HRS
Skeletal Dynamics, LLC
Orthopedic · 57d
Cleared May 12, 2015
OASYS System
K150539 · NKG
Stryker Corporation
Orthopedic · 70d
Cleared May 12, 2015
Mont Blanc Spinal System
K150185 · NKB
Spineway
Orthopedic · 105d
Cleared May 11, 2015
The Octane Straight Intervertebral Fusion Device, Ti Coated
K150152 · MAX
Exactech, Inc.
Orthopedic · 108d
Cleared May 11, 2015
Life Spine Cannulated Screws
K150126 · HWC
Life Spine, Inc.
Orthopedic · 111d
Cleared May 11, 2015
Elite Nitinol Fixation System
K150125 · JDR
Biomedical Enterprises, Inc.
Orthopedic · 111d
Cleared May 11, 2015
Renovis Surgical Hip Replacement System
K143647 · OQG
Renovis Surgical Technologies, Inc.
Orthopedic · 140d
Cleared May 08, 2015
Snap-Off Self-Compressive Screw
K150772 · HWC
Neosteo
Orthopedic · 45d
Cleared May 08, 2015
Subtalar Spacer System (STS)
K150213 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared May 07, 2015
Elite L Expandable Lumbar Fusion System
K150954 · MAX
Innova Spinal Technologies, LLC
Orthopedic · 28d
Cleared May 07, 2015
Tensyn Plug
K150359 · HTN
Dallen Medical, Inc.
Orthopedic · 84d
Cleared May 07, 2015
Blue Mountain Cervical Plate System
K150036 · KWQ
Spineway
Orthopedic · 118d
Cleared May 07, 2015
JAZZ System
K143759 · OWI
Implanet, S.A.
Orthopedic · 127d
Cleared May 07, 2015
Mecta-C TiPEEK
K142744 · ODP
Medacta International
Orthopedic · 225d
Cleared May 07, 2015
Chesapeake Stabilization System
K142487 · OVD
K2m, Inc.
Orthopedic · 245d
Cleared May 04, 2015
Modified Bencox Hip System
K150007 · LPH
Corentec Co., Ltd.
Orthopedic · 122d
Cleared May 01, 2015
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System,...
K150818 · KTT
Zimmer, Inc.
Orthopedic · 35d
Cleared May 01, 2015
Rush Medullary Pins
K150626 · HTY
Zimmer, Inc.
Orthopedic · 51d
Cleared May 01, 2015
G7 Dual Mobility System
K150522 · LPH
Biomet, Inc.
Orthopedic · 60d
Cleared May 01, 2015
Pyrenees Cervical Plate System
K142212 · KWQ
K2m, Inc.
Orthopedic · 262d
Cleared Apr 30, 2015
INCITE ANCHORED CERVICAL INTERBODY DEVICE
K150913 · OVE
Incite Innovation
Orthopedic · 24d
Cleared Apr 30, 2015
G3 Active Plate Large Fragment System
K150649 · HRS
Genesis Fracture Care, Inc.
Orthopedic · 49d
Cleared Apr 29, 2015
aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping,...
K150974 · HWC
Aap Implantate AG
Orthopedic · 16d