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
5593–5616 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 29, 2015
Integra DigiFuse Cannulated Intramedullary Fusion System
K152527 · HWC
Ascension Orthopedics
Orthopedic · 56d
Cleared Oct 29, 2015
Physica PS Knee System
K152008 · JWH
Lima Corporate S.P.A.
Orthopedic · 100d
Cleared Oct 29, 2015
iFuse Implant System
K151718 · OUR
SI-BONE, Inc.
Orthopedic · 126d
Cleared Oct 29, 2015
Small Bone Nail Implant
K151456 · HSB
Vilex IN Tennessee, Inc.
Orthopedic · 150d
Cleared Oct 29, 2015
ARROW Humeral stems size 6 and 16
K150568 · PHX
Fournitures Hospitalieres Industrie
Orthopedic · 237d
Cleared Oct 29, 2015
AVAmax Vertebral Balloon
K150523 · HRX
Care Fusion
Orthopedic · 241d
Cleared Oct 29, 2015
DSM Biomedical DPR Cable
K143716 · JDQ
Dsm Biomedical
Orthopedic · 304d
Cleared Oct 28, 2015
VERTEX(r) Reconstruction System
K152338 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 70d
Cleared Oct 28, 2015
JOURNEY II Uni Tibial Base and Insert
K152315 · HSX
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared Oct 28, 2015
Genesys Spine TiLock2 Spinal System
K152039 · NKB
Genesys Spine
Orthopedic · 98d
Cleared Oct 27, 2015
CD HORIZON Spinal System
K152457 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 60d
Cleared Oct 27, 2015
Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC...
K152169 · JWH
Ortho Development Corporation
Orthopedic · 84d
Cleared Oct 27, 2015
Anchorage 2 CP System
K151769 · HRS
Stryker GmbH
Orthopedic · 119d
Cleared Oct 27, 2015
Acetabular Cup Orientation System
K150780 · PLW
Materialise NV
Orthopedic · 216d
Cleared Oct 27, 2015
Genesis II XLPE Resurfacing Patellar Components
K150241 · JWH
Smith & Nephew, Inc.
Orthopedic · 267d
Cleared Oct 22, 2015
TSolution One w/ACG surgical System
K150741 · OJP
THINK Surgical, Inc.
Orthopedic · 213d
Cleared Oct 21, 2015
JOURNEY II XR Knee System
K152726 · JWH
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 21, 2015
iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate...
K152704 · JWH
Conformis, Inc.
Orthopedic · 30d
Cleared Oct 21, 2015
S4 Cervical Spinal and Occiput Systems
K151938 · NKG
Aesculap Implant Systems, LLC
Orthopedic · 99d
Cleared Oct 21, 2015
H-MAX S Femoral Hip System
K150855 · MEH
Lima Corporate S.P.A.
Orthopedic · 204d
Cleared Oct 21, 2015
NuVasive VuePoint II OCT System
K150474 · NKG
Nu Vasive, Incorporated
Orthopedic · 240d
Cleared Oct 20, 2015
Navio
K152574 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 41d
Cleared Oct 19, 2015
Opticage Expandable Interbody Fusion Device
K152156 · MAX
Interventional Spine, Inc.
Orthopedic · 77d
Cleared Oct 16, 2015
Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System,...
K151648 · NKB
Altus Partners, LLC
Orthopedic · 120d