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
5569–5592 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 16, 2015
Arthrex iBalance TKA System
K152252 · MBH
Arthrex, Inc.
Orthopedic · 98d
Cleared Nov 16, 2015
KYPHON XPEDE Bone Cement
K151227 · NDN
Medtronic
Orthopedic · 193d
Cleared Nov 16, 2015
REDAPT Porous Acetabular Shell and Cemented Liner
K150790 · LPH
Smith & Nephew, Inc.
Orthopedic · 236d
Cleared Nov 13, 2015
Klassic Knee System
K153075 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 21d
Cleared Nov 13, 2015
SIGN Hip Construct (SHC)
K152757 · HSB
Sign Fracture Care International
Orthopedic · 50d
Cleared Nov 13, 2015
PIVOX(tm) Oblique Lateral Spinal System
K152277 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 93d
Cleared Nov 13, 2015
Polaris Spinal System
K151974 · NKB
Biomet Spine
Orthopedic · 120d
Cleared Nov 13, 2015
Humelock II Reversible Shoulder System
K150488 · PHX
Fx Solutions
Orthopedic · 261d
Cleared Nov 12, 2015
VLP Mini-Mod Talus Plates
K152976 · HRS
Smith & Nephew, Inc.
Orthopedic · 35d
Cleared Nov 12, 2015
ATLANTIS Anterior Cervical Plate System
K152623 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 59d
Cleared Nov 12, 2015
Arthrex iBalance TKA System
K152382 · JWH
Arthrex, Inc.
Orthopedic · 80d
Cleared Nov 10, 2015
Integrity Spine Lumbar Interbody Fusion System
K151819 · MAX
Integrity Spine Lumbar Interbody...
Orthopedic · 127d
Cleared Nov 10, 2015
FIBERGRAFT BG Morsels
K151154 · MQV
Prosidyan, Inc.
Orthopedic · 194d
Cleared Nov 10, 2015
EzFuze Implant System
K150211 · HWC
Vilex IN Tennessee, Inc.
Orthopedic · 284d
Cleared Nov 05, 2015
RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws
K152256 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 87d
Cleared Nov 05, 2015
CD HORIZON Spinal System
K152248 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Nov 04, 2015
KATOR Suture Anchor
K152236 · MBI
Kator, LLC
Orthopedic · 86d
Cleared Nov 03, 2015
Talon DistalFix Antegrade/Retrograde Femoral Nail
K152295 · HSB
Orthopedic Designs North America, Inc.
Orthopedic · 82d
Cleared Nov 03, 2015
SternaLock® 360 Sternal Closure System
K151019 · HRS
Biomet Microfixation
Orthopedic · 201d
Cleared Nov 02, 2015
FastFrame External Fixation System - Knee Spanning, FastFrame External...
K151992 · KTT
Zimmer, Inc.
Orthopedic · 105d
Cleared Oct 30, 2015
RECON system-V-TEK-IVP Plates and Screws
K152312 · HRS
Normed Medizin-Technik GmbH
Orthopedic · 74d
Cleared Oct 30, 2015
Frontier Medical Devices In-line Orthopedic Cable Cerclage System
K151888 · JDQ
Frontier Medical Devices, Inc.
Orthopedic · 112d
Cleared Oct 30, 2015
Acumed Ankle and Small Fragment Base Set Update
K151886 · HRS
Acumed, LLC
Orthopedic · 113d
Cleared Oct 30, 2015
MasterLoc Stem
K151531 · LZO
Medacta International
Orthopedic · 144d