510(k) K103558
- Device
- SYNTHES SCOUT VESSEL GUARD
- Applicant
- SYNTHES SPINE
- 510(k) number
- K103558
- Product code
- OMR
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2011-02-18
- Date received
- 2010-12-02
- Regulation
- 870.3470
- Classification name
- Vessel Guard Or Cover
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HEATHER GUERIN
- Address
- 1302 Wrights Ln. E. West Chester PA US 19380 19380
FDA Registration Numbers#
- 3008812560
- 2029275
Source Documents#
Other 510(k) Records For Product Code OMR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111048 | SYNTHES SCOUT TACK FIXATION | Synthes Spine | 2012-06-14 |
| K111137 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | 2011-05-20 |
| K101805 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | 2011-04-08 |
| K101826 | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 | Mimedx Group, Inc. | 2010-07-28 |
| K100984 | XYLOS VESSEL GUARD | Xylos Corporation | 2010-07-07 |
| K100905 | HYDROFIX SURGICAL SHEET | Mimedx Group, Inc. | 2010-06-02 |
| K093551 | PARADIS VASO SHIELD | Spinemedica, LLC | 2009-12-24 |
| K090022 | PARADIS VASO SHIELD | Spinemedica, LLC | 2009-04-20 |
| K082782 | REPLICATION MEDICAL VESSEL GUARD | Replication Medical, Inc. | 2009-04-02 |
Legacy Summary#
summary
FDA Review#
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