DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
FDA 510(k) clearance K092388 · decided 2010-01-21
Clearance details
- K-number
- K092388
- Device name
- DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-08-05
- Decision date
- 2010-01-21
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- GXQ
- Device class
- 2
- Regulation number
- 882.5910
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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| 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
No recalls on record reference this clearance.