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
3433–3456 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 08, 2019
32mm Glenosphere and Humeral Cup
K192206 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 55d
Cleared Oct 08, 2019
Premia Spine XL Instruments
K191854 · OLO
Premia Spine, Ltd.
Orthopedic · 90d
Cleared Oct 08, 2019
Attune Revision LPS Inserts
K191779 · KRO
Depuy(Ireland)
Orthopedic · 98d
Cleared Oct 08, 2019
TSolution One Total Knee Application
K191369 · OLO
THINK Surgical, Inc.
Orthopedic · 139d
Cleared Oct 08, 2019
Bodycad Unicompartmental Knee System
K191150 · HSX
Bodycad Laboratories, Inc.
Orthopedic · 160d
Cleared Oct 07, 2019
PROFEMUR TL2 Stems
K191632 · LZO
Microport Orthopedics, Inc.
Orthopedic · 110d
Cleared Oct 05, 2019
AFX Femoral Implant with Inserter
K192428 · MBI
Cayenne Medical
Orthopedic · 30d
Cleared Oct 04, 2019
Delta Xtend Revers Shoulder System
K192448 · PHX
Depuy(Ireland)
Orthopedic · 28d
Cleared Oct 03, 2019
Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module
K191344 · HRS
Arthrex, Inc.
Orthopedic · 136d
Cleared Oct 03, 2019
CD Horizon™ Astute™ Spinal System
K191066 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 164d
Cleared Oct 03, 2019
SAHARA Stabilization System
K190179 · OVD
K2m, Inc.
Orthopedic · 244d
Cleared Oct 02, 2019
Momentum™ Posterior Spinal Fixation System
K191932 · NKB
Ulrich Medical USA
Orthopedic · 75d
Cleared Oct 01, 2019
BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
K192416 · LZO
Zimmer GmbH
Orthopedic · 27d
Cleared Oct 01, 2019
Intellijoint® Navigation System
K191507 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 117d
Cleared Sep 30, 2019
APTUS Wrist Spanning Plates 2.5
K191848 · HRS
Medartis AG
Orthopedic · 82d
Cleared Sep 27, 2019
MiniMAX
K192352 · LZO
Medacta International S.A.
Orthopedic · 29d
Cleared Sep 27, 2019
Sorrento Bone Graft Substitute
K191074 · MQV
Xenco Medical, LLC
Orthopedic · 157d
Cleared Sep 27, 2019
Precision Spine Navigation Instrumentation
K181606 · OLO
Precision Spine, Inc.
Orthopedic · 465d
Cleared Sep 26, 2019
Genesys Spine Sacroiliac Joint Fusion System
K191748 · OUR
Genesys Spine
Orthopedic · 87d
Cleared Sep 26, 2019
eCarbon IBDs
K191537 · ODP
Back 2 Basics Direct, LLC
Orthopedic · 108d
Cleared Sep 26, 2019
PRECICE System
K191336 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 132d
Cleared Sep 25, 2019
TranS1 Interbody Fusion System
K191791 · MAX
Trans1
Orthopedic · 84d
Cleared Sep 25, 2019
OMNI TiN Coated Apex Knee™ System
K191765 · JWH
Omni Life Science, Inc.
Orthopedic · 86d
Cleared Sep 24, 2019
Innovasis Gibralt Spine System
K192354 · NKG
Innovasis, Inc.
Orthopedic · 26d