The following data is part of a premarket notification filed by Spinal Usa with the FDA for Facet Screw System.
| Device ID | K130863 |
| 510k Number | K130863 |
| Device Name: | FACET SCREW SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | SPINAL USA 1835 MARKET STREET, 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan SPINAL USA 1835 MARKET STREET, 29TH FLOOR Philadelphia, PA 19103 |
| 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 | 2013-03-28 |
| Decision Date | 2013-08-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815362023686 | K130863 | 000 |
| 00815362023440 | K130863 | 000 |
| 00815362023433 | K130863 | 000 |
| 00815362023426 | K130863 | 000 |
| 00815362023419 | K130863 | 000 |
| 00815362023402 | K130863 | 000 |
| 00815362023396 | K130863 | 000 |
| 00815362023389 | K130863 | 000 |
| 00815362023372 | K130863 | 000 |
| 00815362023365 | K130863 | 000 |
| 00815362023358 | K130863 | 000 |
| 00815362023341 | K130863 | 000 |
| 00815362023457 | K130863 | 000 |
| 00815362023464 | K130863 | 000 |
| 00815362023570 | K130863 | 000 |
| 00815362023563 | K130863 | 000 |
| 00815362023556 | K130863 | 000 |
| 00815362023549 | K130863 | 000 |
| 00815362023532 | K130863 | 000 |
| 00815362023525 | K130863 | 000 |
| 00815362023518 | K130863 | 000 |
| 00815362023501 | K130863 | 000 |
| 00815362023495 | K130863 | 000 |
| 00815362023488 | K130863 | 000 |
| 00815362023471 | K130863 | 000 |
| 00840019936231 | K130863 | 000 |