The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Scout Vessel Guard.
| Device ID | K103558 |
| 510k Number | K103558 |
| Device Name: | SYNTHES SCOUT VESSEL GUARD |
| Classification | Vessel Guard Or Cover |
| Applicant | SYNTHES SPINE 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Heather Guerin |
| Correspondent | Heather Guerin SYNTHES SPINE 1302 WRIGHTS LANE 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 | 2010-12-02 |
| Decision Date | 2011-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98108650102S0 | K103558 | 000 |
| H98108650101S0 | K103558 | 000 |