Synthecel Dura Repair, Synthecel Dura Onlay
FDA 510(k) K131792 · Synthes, Inc.
510(k) numberK131792
Submission
- Device name
- Synthecel Dura Repair, Synthecel Dura Onlay
- Applicant
- Synthes, Inc.
West Chester, PA, US - Received
- June 18, 2013
- Decision date
- December 16, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| 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 |
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| K254054 | VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating SystemHRS · Traditional | 03/02/2026SE |
| K243715 | Synthes Patient Specific ImplantsGXN · Traditional | 11/12/2025SE |
| K241927 | Synthes Graphic Case & Tray SystemKCT · Traditional | 03/28/2025SE |
| K233994 | VOLT Proximal Humerus 3.5 Plating SystemHRS · Traditional | 07/26/2024SE |
| K233967 | DePuy Synthes MatrixSTERNUM Fixation SystemHRS · Traditional | 05/09/2024SE |
| K123723 | Synthes Matrixneuro Cranial Plating SystemGWO · Traditional | 09/05/2013SE |
| K122455 | Synthes Small External Fixation System, Synthes Large External Fixation SystemKTT · Traditional | 04/11/2013SE |
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Questions and answers
When was Synthecel Dura Repair, Synthecel Dura Onlay cleared by the FDA?
Synthecel Dura Repair, Synthecel Dura Onlay (K131792) received a 510(k) decision of Substantially Equivalent on December 16, 2013, 181 days after the submission was received.
What is the product code of K131792?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.