Collagen Nerve Wrap
FDA 510(k) K060952 · Collagen Matrix, Inc.
510(k) numberK060952
Submission
- Device name
- Collagen Nerve Wrap
- Applicant
- Collagen Matrix, Inc.
Franklin Lakes, NJ, US - Received
- April 6, 2006
- Decision date
- July 14, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code JXI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260245 | SILKBridgeJXI · Traditional | KLISBio S.r.l. | 04/09/2026SE |
| K253363 | NeuroSpan BridgeJXI · Traditional | Auxilium Biotechnologies, Inc. | 01/17/2026SE |
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)JXI · Traditional | Alafair Biosciences | 07/22/2025SE |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)JXI · Traditional | Alafair Biosciences | 07/17/2025SE |
| K243889 | Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40…JXI · Traditional | Orthocell, Ltd. | 04/02/2025SE |
| K242113 | Nerve Wrap (07-DW-001-TAB)JXI · Traditional | Biocircuit Technologies, Inc. | 04/02/2025SE |
| K233322 | Mochida Nerve CuffJXI · Traditional | Mochida Pharmaceutical Co., Ltd. | 06/21/2024SE |
| K233533 | NerveTapeJXI · Traditional | Biocircuit Technologies, Inc. | 02/12/2024SE |
| K230794 | Rebuilder Nerve Guidance ConduitJXI · Traditional | Celestray Biotech Company, LLC., | 01/29/2024SE |
| K232029 | VersaWrap Nerve ProtectorJXI · Traditional | Alafair Biosciences, Inc. | 11/02/2023SE |
More from Alafair Biosciences, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251191 | Collagen Dura Regeneration Membrane - RepairGXQ · Traditional | 11/18/2025SE |
| K243071 | Bovine Dermis Collagen Dermal MatrixKGN · Traditional | 12/19/2024SE |
| K242302 | RejuvaKnee Collagen Meniscus ImplantOLC · Traditional | 10/02/2024SE |
| K233203 | Soft Tissue Augmentation Resorbable MatrixNPL · Traditional | 05/01/2024SE |
| K240424 | Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixMQV · Traditional | 03/12/2024SE |
| K231942 | Mineral Collagen Composite Bioactive Extra MoldableMQV · Special | 08/02/2023SE |
| K221735 | Mineral Collagen Composite Bioactive MoldableMQV · Traditional | 12/20/2022SE |
| K213341 | Fibrillar Collagen Wound DressingKGN · Traditional | 05/31/2022SE |
| K202183 | Porcine Mineral Collagen CompositeNPM · Traditional | 04/02/2021SE |
| K201859 | Porcine Mineral Collagen Composite MoldableNPM · Traditional | 09/11/2020SE |
Questions and answers
When was Collagen Nerve Wrap cleared by the FDA?
Collagen Nerve Wrap (K060952) received a 510(k) decision of Substantially Equivalent on July 14, 2006, 99 days after the submission was received.
What is the product code of K060952?
The FDA product code is JXI – Cuff, Nerve, a Class II (moderate risk) device regulated under 21 CFR 882.5275.