The following data is part of a premarket notification filed by Spinevision, Inc. with the FDA for P.l.u.s. System (pivot Link Universal System).
| Device ID | K013312 |
| 510k Number | K013312 |
| Device Name: | P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SPINEVISION, INC. 3003 SUMMIT BLVD.; STE 1500 Atlanta, GA 30319 |
| Contact | Lynnette Whitaker |
| Correspondent | Lynnette Whitaker SPINEVISION, INC. 3003 SUMMIT BLVD.; STE 1500 Atlanta, GA 30319 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-04 |
| Decision Date | 2002-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03663136018126 | K013312 | 000 |
| 03663136017884 | K013312 | 000 |
| 03663136020365 | K013312 | 000 |
| 03663136021683 | K013312 | 000 |
| 03663136017945 | K013312 | 000 |
| 03663136017969 | K013312 | 000 |
| 03663136018003 | K013312 | 000 |
| 03663136018027 | K013312 | 000 |
| 03663136018034 | K013312 | 000 |
| 03663136018041 | K013312 | 000 |
| 03663136018058 | K013312 | 000 |
| 03663136018065 | K013312 | 000 |
| 03663136018089 | K013312 | 000 |
| 03663136018096 | K013312 | 000 |
| 03663136018102 | K013312 | 000 |
| 03663136014494 | K013312 | 000 |