The following data is part of a premarket notification filed by Signus Medical Llc. with the FDA for Nubic Spinal Implant.
| Device ID | K052096 |
| 510k Number | K052096 |
| Device Name: | NUBIC SPINAL IMPLANT |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | SIGNUS MEDICAL LLC. 4050 OLSON MEMORIAL HIGHWAY SUITE 350 Minneapolis, MN 55422 |
| Contact | Tracy L Gray |
| Correspondent | Tracy L Gray SIGNUS MEDICAL LLC. 4050 OLSON MEMORIAL HIGHWAY SUITE 350 Minneapolis, MN 55422 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-03 |
| Decision Date | 2005-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04047844010617 | K052096 | 000 |
| 04047844002063 | K052096 | 000 |
| 04047844002070 | K052096 | 000 |
| 04047844002087 | K052096 | 000 |
| 04047844002094 | K052096 | 000 |
| 04047844002100 | K052096 | 000 |
| 04047844002117 | K052096 | 000 |
| 04047844009185 | K052096 | 000 |
| 04047844010532 | K052096 | 000 |
| 04047844010549 | K052096 | 000 |
| 04047844010556 | K052096 | 000 |
| 04047844010563 | K052096 | 000 |
| 04047844010570 | K052096 | 000 |
| 04047844010587 | K052096 | 000 |
| 04047844010594 | K052096 | 000 |
| 04047844009192 | K052096 | 000 |