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 dura substitute
Regulation Description Dura substitute.
Product CodeGXQ
Regulation Number 882.5910
Device Class 2


Premarket Reviews
ManufacturerDecision
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
HELIOS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NURAMI MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Collagen Matrix, Inc. II Feb-24-2022
2 Cook Biotech, Inc. II Jan-10-2025
3 Integra LifeSciences Corp. II Oct-30-2024
4 Medtronic Neurosurgery II Jul-20-2023
-
-