Dura-Patch Model Dp-Xxx
FDA 510(k) K980548 · Bridger Biomed, Inc.
510(k) numberK980548
Submission
- Device name
- Dura-Patch Model Dp-Xxx
- Applicant
- Bridger Biomed, Inc.
Bozeman, MT, US - Received
- February 12, 1998
- Decision date
- May 13, 1998
- 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 |
| K153613 | Cerafix Dura SubstituteGXQ · Traditional | Acera Surgical, Inc. | 03/16/2016SE |
More from Acera Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K003917 | Modification to Fluorotex II Surgical MeshFTL · Traditional | 01/26/2001SE |
| K003906 | Modification to Flurotex Surgical MeshFTL · Traditional | 01/26/2001SE |
| K002351 | Fluorotex II Surgical MeshFTL · Traditional | 08/26/2000SE |
| K994032 | Fluoro-Tex Cardiovascular PatchDXZ · Traditional | 07/07/2000SE |
| K984197 | Fluorotex Surgical MeshFTL · Traditional | 01/07/1999SE |
| K973178 | Fluoro-Tex Surgical MembraneDXZ · Traditional | 11/24/1997SE |
Questions and answers
When was Dura-Patch Model Dp-Xxx cleared by the FDA?
Dura-Patch Model Dp-Xxx (K980548) received a 510(k) decision of Substantially Equivalent on May 13, 1998, 90 days after the submission was received.
What is the product code of K980548?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.