HYDROFIX SURGICAL SHEET
FDA 510(k) clearance K100905 · decided 2010-06-02
Clearance details
- K-number
- K100905
- Device name
- HYDROFIX SURGICAL SHEET
- Applicant
- Mimedx Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-01
- Decision date
- 2010-06-02
- Days to decision
- 62 days
- Clearance type
- Special
- Product code
- OMR
- Device class
- 2
- Regulation number
- 870.3470
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNTHES SCOUT TACK FIXATION (K111048) | Synthes Spine | 2012-06-14 |
| HYDROFIX VASO SHIELD (K111137) | Mimedx Group, Inc. | 2011-05-20 |
| HYDROFIX VASO SHIELD (K101805) | Mimedx Group, Inc. | 2011-04-08 |
| SYNTHES SCOUT VESSEL GUARD (K103558) | Synthes Spine | 2011-02-18 |
| HYDROFIX VASO SHIELD, MODEL HVS-001-0610 (K101826) | Mimedx Group, Inc. | 2010-07-28 |
| XYLOS VESSEL GUARD (K100984) | Xylos Corporation | 2010-07-07 |
| PARADIS VASO SHIELD (K093551) | Spinemedica, LLC | 2009-12-24 |
| PARADIS VASO SHIELD (K090022) | Spinemedica, LLC | 2009-04-20 |
| REPLICATION MEDICAL VESSEL GUARD (K082782) | Replication Medical, Inc. | 2009-04-02 |
Recalls involving this device
No recalls on record reference this clearance.