Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DM
FDA 510(k) K132850 · Rti Surgical, Inc.
510(k) numberK132850
Submission
- Device name
- Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DM
- Applicant
- Rti Surgical, Inc.
Alachua, FL, US - Received
- September 11, 2013
- Decision date
- March 31, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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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| K241555 | Moldable Bone Void Filler and Moldable Bone Void Filler + CCCMQV · Traditional | 02/21/2025SE |
| K230036 | Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple…GAT · Traditional | 06/23/2023SE |
| K172343 | Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D TechnologyMAX · Traditional | 10/23/2017SE |
| K163673 | Fortilink-C with TETRAfuse 3D TechnologyODP · Traditional | 05/23/2017SE |
| K142070 | Fortiva Porcine Dermis, Tutoplast Porcine DermisFTM · Abbreviated | 10/27/2014SE |
Questions and answers
When was Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DM cleared by the FDA?
Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine Pericardium DM (K132850) received a 510(k) decision of Substantially Equivalent on March 31, 2014, 201 days after the submission was received.
What is the product code of K132850?
The FDA product code is GXQ – Dura Substitute, a Class II (moderate risk) device regulated under 21 CFR 882.5910.