BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
FDA premarket approval P980048/S001 · decided 2001-05-02
Approval details
- PMA number
- P980048
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Sulzer Spine-Tech
- Date received
- 2001-04-24
- Decision date
- 2001-05-02
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A STERILIZATION FACILITY LOCATED AT STERIS ISOMEDIX SERVICES, MINNEAPOLIS, MINNESOTA.
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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 |