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510(k) K230316

FlexBand; FlexPatch; FlexBand Plus by International Life Sciences — Product Code OWW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2023
Date Received
February 6, 2023
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 International Life Sciences

  • K200503 — ATL Anchors (September 2, 2020)
  • K192112 — FlexBand Plus (September 27, 2019)

Other clearances for product code OWW

  • K251655 — VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (July 18, 2025)
  • 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)
  • K203267 — The BioBrace Implant (April 30, 2021)
  • K160364 — VersaWrap Tendon Protector (June 10, 2016)
  • K121216 — STR GRAFT (November 21, 2012)