BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE
FDA premarket approval P980048/S003 · decided 2004-10-06
Approval details
- PMA number
- P980048
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAK/C VISTA CERVICAL INTERBODY FUSION DEVICE
- Generic name
- Intervertebral fusion device with bone graft, lumbar
- Applicant
- Sulzer Spine-Tech
- Date received
- 2004-04-12
- Decision date
- 2004-10-06
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MAX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR THE BAK/C VISTA DEVICE, A MODIFICATION TO THE ALREADY APPROVED BAK/C DEVICE. THE BAK/C VISTA DIFFERS FROM THE BAK/C DEVICE IN THE FOLLOWING MANNERS: 1) THE BAK/C VISTA HAS TWO LARGE OFFSET SUPERIOR-INFERIOR (SI) HOLES FOR BONE INGROWTH WHEREAS THE BAK/C HAS MANY SMALL HOLES AT VARIOUS CIRCUMFERENTIAL AND LONGITUDINAL LOCATIONS, AND 2) THE BAK/C VISTA IS MADE OF PEEK OPTIMA LT1 AND THE BAK/C IS MADE OF TITANIUM (TI-6A1-4V). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NA
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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 |