510(k) K111137
- Device
- HYDROFIX VASO SHIELD
- Applicant
- MIMEDX GROUP INC
- 510(k) number
- K111137
- Product code
- OMR
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2011-05-20
- Date received
- 2011-04-22
- Regulation
- 870.3470
- Classification name
- Vessel Guard Or Cover
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SALLY THORSEN
- Address
- 811 Livingston Ct. SE Marietta GA US 30067 30067
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 |
| K101805 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | 2011-04-08 |
| K103558 | SYNTHES SCOUT VESSEL GUARD | Synthes Spine | 2011-02-18 |
| 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases