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510(k) K213163

VersaWrap by Alafair Biosciences, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2021
Date Received
September 28, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Other clearances by Alafair Biosciences, Inc.

  • K251505 — VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (July 22, 2025)
  • K251655 — VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (July 18, 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)
  • 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 FTM

  • K250598 — Endoform Reconstructive Template - PLGA (June 3, 2025)
  • K243595 — OviTex PRS (Long-Term Resorbable) (December 19, 2024)
  • K233991 — CanGaroo RM Antibacterial Envelope (June 14, 2024)
  • K241126 — OviTex PRS (May 22, 2024)
  • K223052 — Peri-Guard and Supple Peri-Guard (April 7, 2023)
  • K214070 — OviTex PRS (Long Term Resorbable) (March 21, 2023)
  • K213125 — PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECU (October 27, 2021)
  • K203496 — Nexo-Gide Bilayer Collagen Membrane (July 14, 2021)
  • K203600 — VersaWrap (March 9, 2021)
  • K192452 — Lyograft (September 3, 2020)