DURAFORM Dural Graft Implant
FDA 510(k) clearance K152481 · decided 2015-10-30
Clearance details
- K-number
- K152481
- Device name
- DURAFORM Dural Graft Implant
- Applicant
- Codman & Shurtleff, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-31
- Decision date
- 2015-10-30
- Days to decision
- 60 days
- Clearance type
- Special
- Product code
- GXQ
- Device class
- 2
- Regulation number
- 882.5910
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| Collagen Dura Regeneration Membrane - Repair (K251191) | Collagen Matrix, Inc. | 2025-11-18 |
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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 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 recall (Z-0262-2025) | Integra LifeSciences Corp. | 2024-10-30 |