Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Spinal Vertebral Body Replacement Device - Cervical
510(k) Number K252822
Device Name Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant
Applicant
Atlas Spine, Inc.
1555 Jupiter Park Dr.
Suite 1
Jupiter,  FL  33458
Applicant Contact Thomas Smith
Correspondent
Atlas Spine, Inc.
1555 Jupiter Park Dr.
Suite 1
Jupiter,  FL  33458
Correspondent Contact Patrick Kennedy
Regulation Number888.3060
Classification Product Code
PLR  
Date Received09/04/2025
Decision Date 07/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-