DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE
FDA premarket approval P970015/S019 · decided 2001-07-19
Approval details
- PMA number
- P970015
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DUAL INTERFIX-RP(TM) THREADED FUSION DEVICE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Sofamor Danek
- Date received
- 2001-04-09
- Decision date
- 2001-07-19
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR USE OF DUAL INTERFIX-RP(TM) THREADED FURSION DEVICES (INSTEAD OF THE ALREADY APPROVED USE OF A SINGLE INTERFIX-RP(TM) THREADED FUSION DEVICE USED IN CONJUNCTION WITH AN INTERFIX(TM) THREADED FUSION DEVICE) THE UNMODIFIED DEVICE WILL CONTINUE TO BE MARKETED UNDER THE TRADE NAME INTERFIX-RP(TM) THREADED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WTIH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. DDD IS DEFINED AS DISCOGENIC BAC
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM (K991460) | Sofamor Danek | 1999-05-19 |