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 |