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
3553–3576 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 29, 2019
CoLink® Mini Plating System
K191535 · HRS
In2bones USA, LLC
Orthopedic · 49d
Cleared Jul 29, 2019
Bone Screw Line Addition
K191289 · HWC
Vilex IN Tennessee, Inc.
Orthopedic · 77d
Cleared Jul 28, 2019
Bonus Therapeutics Mixing and Delivery System
K190996 · FMF
Bonus Therapeutics , Ltd.
Orthopedic · 103d
Cleared Jul 26, 2019
ActivOrtho Continuous Compression Screw System
K191817 · HWC
Activortho, Inc.
Orthopedic · 21d
Cleared Jul 26, 2019
Arthrex Eclipse Shoulder Prosthesis System
K183194 · QHQ
Arthrex, Inc.
Orthopedic · 249d
Cleared Jul 26, 2019
Medtronic Total Hip Arthroplasty System
K183129 · LPH
Medtronic Advanced Energy
Orthopedic · 255d
Cleared Jul 25, 2019
JOURNEY II Unicompartmental Knee System
K191211 · HSX
Smith & Nephew, Inc.
Orthopedic · 80d
Cleared Jul 25, 2019
RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant
K190774 · MBI
Medos International SARL
Orthopedic · 121d
Cleared Jul 25, 2019
Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable...
K183249 · MAX
Stryker Spine
Orthopedic · 246d
Cleared Jul 25, 2019
Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer
K183017 · JWH
Osteoremedies, LLC
Orthopedic · 267d
Cleared Jul 24, 2019
ExcelsiusGPS Spine 1.1 Interbody Module
K191100 · OLO
Globus Medical, Inc.
Orthopedic · 90d
Cleared Jul 24, 2019
4CIS® Chiron Spinal Fixation System
K190471 · NKB
Solco Biomedical Co., Ltd.
Orthopedic · 148d
Cleared Jul 23, 2019
DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
K190963 · HRS
Synthes USA Products, LLC
Orthopedic · 102d
Cleared Jul 23, 2019
Hammertoe Truss System (HTS)
K190926 · HTY
4Web, Inc.
Orthopedic · 105d
Cleared Jul 23, 2019
ProLift Expandable System
K190488 · MAX
Life Spine, Inc.
Orthopedic · 145d
Cleared Jul 22, 2019
Revival Modular Hip Stem
K191374 · LZO
Corin U.S.A. Limited
Orthopedic · 60d
Cleared Jul 22, 2019
Corin Optimized Position System Functional Hip Analysis (OPS FHA)
K190834 · LZO
Corin USA
Orthopedic · 112d
Cleared Jul 19, 2019
EUROPA Pedicle Screw System
K191757 · NKB
MiRus, LLC
Orthopedic · 18d
Cleared Jul 19, 2019
Mariner MIS Pedicle Screw System
K191648 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 29d
Cleared Jul 18, 2019
SPAR-K Instruments (for use with Gemini SL Total Knee System)
K191755 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 17d
Cleared Jul 18, 2019
AOS ES Retrograde Femoral Nail
K191598 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 31d
Cleared Jul 18, 2019
MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY...
K190895 · NKG
Medos International SARL
Orthopedic · 104d
Cleared Jul 18, 2019
FAVO S-TLIF
K190680 · MAX
Silony Medical GmbH
Orthopedic · 122d
Cleared Jul 18, 2019
Latitud Hip Replacement System
K183532 · LZO
Meril Healthcare Pvt. , Ltd.
Orthopedic · 211d