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

TPLC - Total Product Life Cycle
  • 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 show TPLC since Back to Search Results
Device anterior staple as supplemental fixation for fusion
Definition Anterior cervical device for supplemental fixation to support a fusion.
Product CodePHQ
Regulation Number 888.3060
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
PRESSIO, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Dysphagia/ Odynophagia 1 1

-
-