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510(k) K010051

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE by Xiros Plc — Product Code JDR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2001
Date Received
January 8, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Xiros Plc

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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)
  • K151601 — SECURE-LOOP (September 9, 2015)
  • K002172 — POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS) (August 28, 2001)

Other clearances for product code JDR

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  • K243888 — Medline UNITE® REFLEX® Hybrid Nitinol Implant System (April 11, 2025)
  • K243742 — Arthrex DynaNite Nitinol Staples (January 31, 2025)
  • K243658 — TMC Compression Implant System (December 26, 2024)
  • K242415 — TMC Compression Implant System (September 6, 2024)
  • K240212 — COGNiTiON™ Staple System (February 23, 2024)
  • K232990 — A’TOMIC™ Nitinol Fixation System (January 12, 2024)
  • K230724 — arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (December 4, 2023)
  • K232905 — Medline UNITE® REFLEX® Nitinol Staple Kit (October 19, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)