LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE
FDA premarket approval P970015/S022 · decided 2003-09-10
Approval details
- PMA number
- P970015
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Sofamor Danek
- Date received
- 2002-10-30
- Decision date
- 2003-09-10
- Days to decision
- 315 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR THE LT-CAGE PEEK LUMBER TAPERED FUSION DEVICE, WHICH IS MANUFACTURED FROM POLYETHERETHERKE-TONE, WITH THE TRADE NAME OF PEEK-OPTIMA LT1. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE AND IS INDICATED FOR SPINAL FUSION PROCEDURES IN SKELETALLY MATURE PATIENTS WITH DEGERNERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L2-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADI
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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 |