SECURE -C CERVICAL ARTIFICIAL DISC
FDA premarket approval P100003/S006 · decided 2016-05-17
Approval details
- PMA number
- P100003
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SECURE -C CERVICAL ARTIFICIAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Globus Medical, Inc.
- Date received
- 2015-07-01
- Decision date
- 2016-05-17
- Days to decision
- 321 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Audubon, PA
- Statement
- Approval for clarifying the worst-case temperature rise for the subject device and revising the labeling to adequately reflect those temperature. The Secure-C Cervical Artificial Disc can be now be labeled as MR Compatible.
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