Cerafix Dura Substitute
FDA 510(k) K153613 · Acera Surgical, Inc.
510(k) numberK153613
Submission
- Device name
- Cerafix Dura Substitute
- Applicant
- Acera Surgical, Inc.
St. Louis, MO, US - Received
- December 17, 2015
- Decision date
- March 16, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - RepairGXQ · Traditional | Collagen Matrix, Inc. | 11/18/2025SE |
| K250420 | Helios Dura Regeneration MatrixGXQ · Traditional | Helios Biomedical, Inc. | 05/14/2025SE |
| K223445 | ArtiFasciaGXQ · Traditional | Nurami Medical , Ltd. | 08/10/2023SE |
| K212943 | SyntheCel Dura RepairGXQ · Traditional | Synthes (USA) Products, LLC | 01/28/2022SE |
| K183513 | XenoSure Dura Biologic PatchGXQ · Traditional | LeMaitre Vascular, Inc. | 06/13/2019SE |
| K172603 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 11/27/2017SE |
| K163456 | DuraGen Secure Dural Regeneration MatrixGXQ · Special | Integra LifeSciences Corporation | 01/06/2017SE |
| K161370 | Durepair Dura Regeneration MatrixGXQ · Traditional | Medtronic Neurosurgery | 11/02/2016SE |
| K161278 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 08/08/2016SE |
| K150825 | Collagen Dural Regeneration MatrixGXQ · Traditional | Collagen Matrix, Inc. | 11/20/2015SE |
More from Collagen Matrix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251224 | Restrata Soft Tissue Reinforcement (STR)OXF · Traditional | 06/20/2025SE |
| K223725 | Restrata® MiniMatrixQSZ · Traditional | 05/18/2023SE |
| K193583 | Restrata®QSZ · Special | 09/25/2020SE |
| K172603 | Cerafix Dura SubstituteGXQ · Traditional | 11/27/2017SE |
| K170300 | Restrata Wound MatrixQSZ · Traditional | 04/26/2017SE |
| K161278 | Cerafix Dura SubstituteGXQ · Traditional | 08/08/2016SE |
Questions and answers
When was Cerafix Dura Substitute cleared by the FDA?
Cerafix Dura Substitute (K153613) received a 510(k) decision of Substantially Equivalent on March 16, 2016, 90 days after the submission was received.
What is the product code of K153613?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.