The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Scout Tack Fixation.
| Device ID | K111048 |
| 510k Number | K111048 |
| Device Name: | SYNTHES SCOUT TACK FIXATION |
| Classification | Vessel Guard Or Cover |
| Applicant | SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester, PA 19380 |
| Contact | Heather Guerin |
| Correspondent | Heather Guerin SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester, PA 19380 |
| Product Code | OMR |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-15 |
| Decision Date | 2012-06-14 |
| Summary: | summary |