BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
FDA premarket approval P980048 · decided 2001-04-20
Approval details
- PMA number
- P980048
- Trade name
- BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Sulzer Spine-Tech
- Date received
- 1998-12-15
- Decision date
- 2001-04-20
- Days to decision
- 857 days
- Decision code
- APRL
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- Yes
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE BAK/CERVICAL (BAK/C(R)) INTERBODY FUSION SYSTEM. THE DEVICE IS INDICATED FOR USE IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) OF THE CERVICAL SPINE WITH ACCOMPANYING RADICULAR SYMPTOMS AT ONE DISC LEVEL. DDD IS DEFINED AS DISCOGENIC PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY HISTORY AND RADIOGRAPHIC STUDIES. BAK/C IMPLANTS ARE USED TO FACILITATE FUSION IN THE CERVICAL SPINE AND ARE PLACED VIA AN ANTERIOR APPROACH AT THE C-3 TO C-7 DISC LEVELS USING AUT
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CADENCE SPINAL FIXATION SYSTEM (K022374) | Sulzer Spine-Tech | 2002-09-24 |
| RPX TITANIUM CEMNT RESTRICTOR (K020344) | Sulzer Spine-Tech | 2002-05-02 |
| MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM (K020196) | Sulzer Spine-Tech | 2002-02-15 |
| DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM (K012173) | Sulzer Spine-Tech | 2001-09-28 |
| MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM (K012305) | Sulzer Spine-Tech | 2001-08-22 |
| SILHOUETTE SPINAL FIXATION SYSTEM (K993067) | Sulzer Spine-Tech | 1999-11-16 |
| MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM (K992276) | Sulzer Spine-Tech | 1999-10-01 |