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
2785–2808 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 16, 2020
Circular Fixation with Balanced Cable Transport
K202762 · KTT
Smith & Nephew, Inc.
Orthopedic · 56d
Cleared Nov 16, 2020
EVOS Large Fragment Plating System
K201918 · HRS
Smith & Nephew, Inc.
Orthopedic · 129d
Cleared Nov 13, 2020
TSolution One Total Knee Application
K203040 · OLO
THINK Surgical, Inc.
Orthopedic · 38d
Cleared Nov 13, 2020
Monster Screw System
K203011 · HWC
Paragon 28, Inc.
Orthopedic · 43d
Cleared Nov 13, 2020
APEX 3D Total Ankle Replacement System
K202373 · HSN
Paragon 28, Inc.
Orthopedic · 86d
Cleared Nov 13, 2020
Stryker Omega PEEK Knotless Anchor System
K202355 · MBI
Stryker
Orthopedic · 86d
Cleared Nov 13, 2020
VersaLoop Anchor System
K202178 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 101d
Cleared Nov 12, 2020
Calvary Spine Pedicle Screw System
K201568 · NKB
Calvary Spine, LLC
Orthopedic · 154d
Cleared Nov 12, 2020
AGILON® XO Shoulder Replacement System
K191433 · HSD
Implantcast GmbH
Orthopedic · 533d
Cleared Nov 10, 2020
Multi-Drive Interference Screw System
K200428 · MBI
Nvision Biomedical Technologies, Inc.
Orthopedic · 263d
Cleared Nov 10, 2020
WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw...
K193214 · MBI
Biomet, Inc.
Orthopedic · 355d
Cleared Nov 09, 2020
iFuse Implant System - iFuse Navigation
K203110 · OLO
SI-BONE, Inc.
Orthopedic · 25d
Cleared Nov 09, 2020
Vantage PSI System
K193432 · OYK
3D Systems
Orthopedic · 335d
Cleared Nov 06, 2020
Mecta-C Stand Alone Extension
K203076 · OVE
Medacta International S.A.
Orthopedic · 24d
Cleared Nov 06, 2020
ATEC Lateral Interbody System
K202587 · MAX
Alphatec Spine, Inc.
Orthopedic · 59d
Cleared Nov 05, 2020
KASILOF Cervical Plate System
K203154 · KWQ
Kahtnu Surgical, Inc.
Orthopedic · 14d
Cleared Nov 05, 2020
Salvo® Spine System
K202476 · NKB
Spine Wave, Inc.
Orthopedic · 69d
Cleared Nov 04, 2020
Z-Span Plate System
K202624 · KWQ
Zavation Medical Products, LLC
Orthopedic · 55d
Cleared Nov 04, 2020
Arthrex TightRope II
K202581 · MBI
Arthrex, Inc.
Orthopedic · 57d
Cleared Nov 03, 2020
FlareHawk Interbody Fusion System
K202198 · MAX
Integrity Implants, Inc.
Orthopedic · 90d
Cleared Nov 02, 2020
Midas Rex Attachments and Dissecting Tools
K202552 · OLO
Medtronic Powered Surgical Solutions...
Orthopedic · 60d
Cleared Oct 30, 2020
Atlas Spine Rebar (Ti) Spacer System
K202302 · ODP
Atlas Spine, Inc.
Orthopedic · 77d
Cleared Oct 30, 2020
UNiD IB3D ALIF
K200316 · MAX
Medicrea International SA
Orthopedic · 266d
Cleared Oct 29, 2020
CONSTRUX Mini PEEK Spacer System
K202949 · ODP
Orthofix, Inc.
Orthopedic · 29d