BRYAN (TM) CERVICAL DISC
FDA premarket approval P060023/S006 · decided 2018-01-31
Approval details
- PMA number
- P060023
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRYAN (TM) CERVICAL DISC
- Generic name
- Prosthesis, intervertebral disc
- Applicant
- Companion Spine France Sas
- Date received
- 2017-07-13
- Decision date
- 2018-01-31
- Days to decision
- 202 days
- Decision code
- APPR
- Product code
- MJO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Merignac
- Statement
- Approval for manufacturing sites located at MedTorque, Inc., 612 W. Lamont Road, Elmhurst, Illinois, for instrument machining and laser marking of the BRYAN and PRESTIGE LP instruments, and at Medtronic Sofamor Danek USA, Inc., 4340 Swinnea Road, Memphis, Tennessee, for the manufacturing of PRESTIGE LP Streamlined Instrument.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.