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510(k) K222978

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device by Xiros, Ltd. — Product Code QUW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2022
Date Received
September 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
Device Class
Class II
Regulation Number
878.3300
Review Panel
OR
Submission Type

a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.

Other clearances by Xiros, Ltd.

  • K230671 — Pitch PaSoft Tissue Reinforcement Device (May 31, 2023)
  • K220091 — Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (August 26, 2022)
  • K220906 — SECURE-LOCK (July 22, 2022)
  • K211563 — Pitch-Patchs (August 13, 2021)
  • K191053 — Xtreme-Loop (July 17, 2019)
  • K180243 — Infinity-Lock Button System (April 3, 2018)
  • K171680 — Infinity-Lock 3, Infinity-Lock 5 (June 30, 2017)
  • K151601 — SECURE-LOOP (September 9, 2015)
  • K002172 — POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) (August 28, 2001)
  • K010051 — POLY-TAPES WITH THE FASTLOK FIXATION DEVICE (July 13, 2001)

Other clearances for product code QUW

  • K242237 — Jewel Soft Tissue Reinforcement Device (102-6005) (July 15, 2025)
  • K251063 — TekBrace Solo Soft Tissue Reinforcement Device (May 30, 2025)