BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM
FDA premarket approval P980048/S002 · decided 2002-06-19
Approval details
- PMA number
- P980048
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- BAK/CERVICAL (BAK/C) (R) INTERBODY FUSION SYSTEM
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Sulzer Spine-Tech
- Date received
- 2001-06-22
- Decision date
- 2002-06-19
- Days to decision
- 362 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL FOR THE BAC/C DEVICE. THE POST-APPROVAL STUDY HAS BEEN SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE APRIL 20, 2001, APPROVAL ORDER FOR P980048.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |