|
Device | SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE) |
Generic Name | Prosthesis, ankle, uncemented, non-constrained |
Applicant | DJO Global 9800 Metric Boulevard Austin, TX 78758 |
PMA Number | P050050 |
Supplement Number | S004 |
Date Received | 09/04/2012 |
Decision Date | 05/01/2013 |
Product Code |
NTG |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZRINSKI AG IN WURMLINGEN, GERMANY. |