FDA Product Code
FDA Product Code OMR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3470
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111048 | SYNTHES SCOUT TACK FIXATION | Synthes Spine | 2012-06-14 | Traditional | PDF ↗ |
| K111137 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | 2011-05-20 | Special | PDF ↗ |
| K101805 | HYDROFIX VASO SHIELD | Mimedx Group, Inc. | 2011-04-08 | Traditional | PDF ↗ |
| K103558 | SYNTHES SCOUT VESSEL GUARD | Synthes Spine | 2011-02-18 | Traditional | PDF ↗ |
| K101826 | HYDROFIX VASO SHIELD, MODEL HVS-001-0610 | Mimedx Group, Inc. | 2010-07-28 | Special | PDF ↗ |
| K100984 | XYLOS VESSEL GUARD | Xylos Corporation | 2010-07-07 | Traditional | PDF ↗ |
| K100905 | HYDROFIX SURGICAL SHEET | Mimedx Group, Inc. | 2010-06-02 | Special | PDF ↗ |
| K093551 | PARADIS VASO SHIELD | Spinemedica, LLC | 2009-12-24 | Special | PDF ↗ |
| K090022 | PARADIS VASO SHIELD | Spinemedica, LLC | 2009-04-20 | Traditional | PDF ↗ |
| K082782 | REPLICATION MEDICAL VESSEL GUARD | Replication Medical, Inc. | 2009-04-02 | Traditional | PDF ↗ |
Product code OMR · Class II · Cardiovascular. Data: openFDA.