SyntheCel Dura Repair
FDA 510(k) K212943 · Synthes (USA) Products, LLC
510(k) numberK212943
Submission
- Device name
- SyntheCel Dura Repair
- Applicant
- Synthes (USA) Products, LLC
West Chester, PA, US - Received
- September 15, 2021
- Decision date
- January 28, 2022
- 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 |
| 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 |
| K150825 | Collagen Dural Regeneration MatrixGXQ · Traditional | Collagen Matrix, Inc. | 11/20/2015SE |
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| K192702 | DePuy Synthes Craniomaxillofacial Neuro Devices - MR ConditionalGXN · Traditional | 09/18/2020SE |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)JEY · Special | 09/10/2020SE |
| K201578 | DePuy Synthes Variable Angle Locking Patella Plating SystemHRS · Traditional | 09/09/2020SE |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional | 09/03/2020SE |
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Questions and answers
When was SyntheCel Dura Repair cleared by the FDA?
SyntheCel Dura Repair (K212943) received a 510(k) decision of Substantially Equivalent on January 28, 2022, 135 days after the submission was received.
What is the product code of K212943?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.