INTER FIX THREADED FUSION DEVICE
FDA premarket approval P970015 · decided 1999-05-14
Approval details
- PMA number
- P970015
- Trade name
- INTER FIX THREADED FUSION DEVICE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Sofamor Danek
- Date received
- 1997-03-25
- Decision date
- 1999-05-14
- Days to decision
- 780 days
- Decision code
- APRL
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approvalf or the INTER FIX(TM) Threaded Fusion Device. This device is indicated for spinal fusion procedures in skeletally mature patients with degenerative 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 radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. INTER FIX(TM) implants are indicated to be used with autogenous bone
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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 |