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 mesh, surgical, absorbable, orthopaedics, reinforcement of tendon
Definition For reinforcement of soft tissue where weakness exists during tendon repair procedures.
Product CodeOWW
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
ALAFAIR BIOSCIENCES INC
  SUBSTANTIALLY EQUIVALENT 1
CELESTRAY BIOTECH COMPANY, LLC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL LIFE SCIENCES
  SUBSTANTIALLY EQUIVALENT 1
SOFT TISSUE REGENERATION, INC.
  SUBSTANTIALLY EQUIVALENT 1

-
-