FDA PMA
Approved
🇺🇸 United States
PMA: P970015
·
Supplement: S011
·
Decision Jun 6, 2000
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- INTER FIX III THREADED FUSION DEVICE
- PMA Number
- P970015
- Supplement Number
- S011
- Advisory Committee
- Orthopedic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- June 6, 2000
- Date Received
- December 21, 1999
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR ADDITION OF HOLES IN THE ENDCAPS OF THE INTER FIX(TM) THREADED FUSION DEVICE.