Home / 510(k) Clearances / K251655

510(k) K251655

VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) by Alafair Biosciences — Product Code OWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2025
Date Received
May 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

For reinforcement of soft tissue where weakness exists during tendon repair procedures.

Other clearances by Alafair Biosciences

  • K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (July 22, 2025)
  • K251175 — VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) (July 17, 2025)
  • K240817 — VersaWrap (June 14, 2024)
  • K232029 — VersaWrap Nerve Protector (November 2, 2023)
  • K213163 — VersaWrap (October 29, 2021)
  • K203600 — VersaWrap (March 9, 2021)
  • K201631 — VersaWrap Nerve Protector (September 14, 2020)
  • K200311 — VersaWrap Tendon Protector (March 6, 2020)
  • K160364 — VersaWrap Tendon Protector (June 10, 2016)

Other clearances for product code OWW

  • K250021 — Rotium (February 27, 2025)
  • K242187 — BioBrace® (November 27, 2024)
  • K241906 — BioBrace® Reinforced Implant (July 29, 2024)
  • K240817 — VersaWrap (June 14, 2024)
  • K222220 — SpinMedix Absorbable Fibrous Membrane (July 6, 2023)
  • K230316 — FlexBand; FlexPatch; FlexBand Plus (May 26, 2023)
  • K203267 — The BioBrace Implant (April 30, 2021)
  • K160364 — VersaWrap Tendon Protector (June 10, 2016)
  • K121216 — STR GRAFT (November 21, 2012)