The following data is part of a premarket notification filed by Spinevision, Inc. with the FDA for Plus Pivot Link Universal System.
| Device ID | K032398 |
| 510k Number | K032398 |
| Device Name: | PLUS PIVOT LINK UNIVERSAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINEVISION, INC. 3003 SUMMIT BLVD. STE 1500 Atlanta, GA 30319 |
| Contact | Lynette Whitaker |
| Correspondent | Lynette Whitaker SPINEVISION, INC. 3003 SUMMIT BLVD. STE 1500 Atlanta, GA 30319 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-04 |
| Decision Date | 2003-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03663136015248 | K032398 | 000 |
| 03663136015231 | K032398 | 000 |