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510(k) K151601

SECURE-LOOP by Xiros, Ltd. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2015
Date Received
June 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Xiros, Ltd.

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  • 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)
  • K002172 — POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) (August 28, 2001)
  • K010051 — POLY-TAPES WITH THE FASTLOK FIXATION DEVICE (July 13, 2001)

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