VersaWrap Tendon Protector
FDA 510(k) K200311 · Alafair Biosciences, Inc.
510(k) numberK200311
Submission
- Device name
- VersaWrap Tendon Protector
- Applicant
- Alafair Biosciences, Inc.
Austin, TX, US - Received
- February 6, 2020
- Decision date
- March 6, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)JXI · Traditional | 07/22/2025SE |
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1)OWW · Traditional | 07/18/2025SE |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)JXI · Traditional | 07/17/2025SE |
| K240817 | VersaWrapOWW · Traditional | 06/14/2024SE |
| K232029 | VersaWrap Nerve ProtectorJXI · Traditional | 11/02/2023SE |
| K213163 | VersaWrapFTM · Special | 10/29/2021SE |
| K203600 | VersaWrapFTM · Traditional | 03/09/2021SE |
| K201631 | VersaWrap Nerve ProtectorJXI · Traditional | 09/14/2020SE |
| K160364 | VersaWrap Tendon ProtectorOWW · Traditional | 06/10/2016SE |
Questions and answers
When was VersaWrap Tendon Protector cleared by the FDA?
VersaWrap Tendon Protector (K200311) received a 510(k) decision of Substantially Equivalent on March 6, 2020, 29 days after the submission was received.
What is the product code of K200311?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.