BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
FDA 510(k) clearance K132850 · decided 2014-03-31
Clearance details
- K-number
- K132850
- Device name
- BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM
- Applicant
- Rti Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-11
- Decision date
- 2014-03-31
- Days to decision
- 201 days
- Clearance type
- Traditional
- Product code
- GXQ
- Device class
- 2
- Regulation number
- 882.5910
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Alachua, FL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| XenoSure Dura Biologic Patch (K183513) | LeMaitre Vascular, Inc. | 2019-06-13 |
| Cerafix Dura Substitute (K172603) | Acera Surgical, Inc. | 2017-11-27 |
| DuraGen Secure Dural Regeneration Matrix (K163456) | Integra LifeSciences Corporation | 2017-01-06 |
| Durepair Dura Regeneration Matrix (K161370) | Medtronic Neurosurgery | 2016-11-02 |
| Cerafix Dura Substitute (K161278) | Acera Surgical, Inc. | 2016-08-08 |
| Cerafix Dura Substitute (K153613) | Acera Surgical, Inc. | 2016-03-16 |
| Collagen Dural Regeneration Matrix (K150825) | Collagen Matrix, Inc. | 2015-11-20 |
| DURAFORM Dural Graft Implant (K152481) | Codman & Shurtleff, Inc. | 2015-10-30 |
Recalls involving this device
No recalls on record reference this clearance.