The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Facet Screw System.
| Device ID | K101284 |
| 510k Number | K101284 |
| Device Name: | FACET SCREW SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Contact | Sheila Bruschi |
| Correspondent | Sheila Bruschi NUVASIVE, INC. 7475 LUSK BLVD San Diego, CA 92121 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-07 |
| Decision Date | 2010-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517259387 | K101284 | 000 |
| 00887517255785 | K101284 | 000 |
| 00887517255778 | K101284 | 000 |
| 00887517255761 | K101284 | 000 |
| 00887517255754 | K101284 | 000 |
| 00887517255747 | K101284 | 000 |
| 00887517255723 | K101284 | 000 |
| 00887517255716 | K101284 | 000 |
| 00887517255709 | K101284 | 000 |
| 00887517255396 | K101284 | 000 |
| 00887517255389 | K101284 | 000 |
| 00887517255372 | K101284 | 000 |
| 00887517255365 | K101284 | 000 |
| 00887517255792 | K101284 | 000 |
| 00887517256102 | K101284 | 000 |
| 00887517257109 | K101284 | 000 |
| 00887517259370 | K101284 | 000 |
| 00887517259363 | K101284 | 000 |
| 00887517259356 | K101284 | 000 |
| 00887517259349 | K101284 | 000 |
| 00887517259332 | K101284 | 000 |
| 00887517259325 | K101284 | 000 |
| 00887517257161 | K101284 | 000 |
| 00887517257154 | K101284 | 000 |
| 00887517257147 | K101284 | 000 |
| 00887517257130 | K101284 | 000 |
| 00887517257123 | K101284 | 000 |
| 00887517257116 | K101284 | 000 |
| 00887517251091 | K101284 | 000 |