|
Device | PRODISC-C TOTAL DISC REPLACEMENT |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Centinel Spine, LLC 900 Airport Road, Suite 3B West Chester, PA 19380 |
PMA Number | P070001 |
Supplement Number | S015 |
Date Received | 06/30/2017 |
Decision Date | 07/27/2017 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change to the holding fixture and coordinate measuring machine (CMM) software programs used to dimensionally inspect the ProDisc-C Total Disc Replacement inferior and superior plates. |