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
3169–3192 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 18, 2020
LINK TrabecuLink Tibial Cones
K200113 · MBH
Waldemar Link GmbH & Co. KG
Orthopedic · 61d
Cleared Mar 18, 2020
HEALICOIL Knotless Suture Anchors
K193558 · MAI
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Mar 17, 2020
iBalance UKA Tibial Tray Implant
K200433 · HSX
Arthrex, Inc.
Orthopedic · 25d
Cleared Mar 17, 2020
Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral,...
K200151 · HSX
Zimmer, Inc.
Orthopedic · 55d
Cleared Mar 16, 2020
Response BandLoc Spinal Fixation
K200097 · OWI
OrthoPediatrics Corp.
Orthopedic · 60d
Cleared Mar 13, 2020
LEGION Inserts with JRNY Lock
K200407 · JWH
Smith & Nephew, Inc.
Orthopedic · 23d
Cleared Mar 13, 2020
3DMetal Diaphyseal Femoral Cones
K200075 · JWH
Medacta International S.A.
Orthopedic · 59d
Cleared Mar 13, 2020
SeaSpine Skipjack System
K193418 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 95d
Cleared Mar 13, 2020
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair...
K193105 · JWH
Conformis, Inc.
Orthopedic · 126d
Cleared Mar 12, 2020
Arthrex FiberTak Suture Anchor
K200341 · MBI
Arthrex, Inc.
Orthopedic · 30d
Cleared Mar 12, 2020
Tritium Sternal Cable Plate System
K193468 · JDQ
Pioneer Surgical Technology, Inc....
Orthopedic · 87d
Cleared Mar 11, 2020
Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous...
K200328 · OQG
Kyocera Medical Technologies, Inc.
Orthopedic · 30d
Cleared Mar 11, 2020
KLS Martin Individual Patient Solutions (IPS) Planning System
K192979 · PBF
KLS-Martin L.P.
Orthopedic · 139d
Cleared Mar 11, 2020
Apollo Suture Anchor System
K192810 · MBI
Valeris Medical
Orthopedic · 162d
Cleared Mar 11, 2020
Fixone Biocomposite Anchor
K192484 · MAI
Aju Pharm Co., Ltd.
Orthopedic · 183d
Cleared Mar 09, 2020
MectaLIF Anterior Simple
K200048 · MAX
Medacta International S.A.
Orthopedic · 60d
Cleared Mar 06, 2020
LOSPA® IS™ Spinal Fixation System
K200267 · NKB
Corentec Co., Ltd.
Orthopedic · 32d
Cleared Mar 06, 2020
MEGAFIX® Pedicle Screw Spinal System
K191655 · NKB
Seohancare Co., Ltd.
Orthopedic · 259d
Cleared Mar 06, 2020
OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant
K190652 · HTY
OSSIO , Ltd.
Orthopedic · 359d
Cleared Mar 05, 2020
ALLthread PEEK Suture Anchor
K193402 · MBI
Biomet, Inc.
Orthopedic · 90d
Cleared Mar 05, 2020
V-STRUT Vertebral Implant
K191709 · NDN
Hyprevention Sas
Orthopedic · 253d
Cleared Mar 04, 2020
Coronet Soft Tissue Fixation System
K200028 · MBI
Conextions Medical
Orthopedic · 58d
Cleared Mar 04, 2020
ARIX Ankle System
K193616 · HRS
Jeil Medical Corporation
Orthopedic · 69d
Cleared Mar 04, 2020
Mecta-C Stand Alone
K192906 · OVE
Medacta International S.A.
Orthopedic · 141d