|
Device | EXATECH NOVATION CERAMIC AHS ARTICULATION HIP SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 |
PMA Number | P050039 |
Supplement Number | S007 |
Date Received | 10/07/2011 |
Decision Date | 04/27/2012 |
Withdrawal Date
|
12/31/2020 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR USE OF AN ADDITIONAL PACKAGE SEALER FOR THE ACETABULAR LINER AND FEMORAL HEAD STERILE BARRIER PACKAGING PROCESSES. |