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510(k) K232755

Arthrex FiberTape and TigerTape Cerclage Sutures by Arthrex, Inc. — Product Code HTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2023
Date Received
September 8, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Washer, Bolt Nut
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K240947 — TENSOR® Suture Button System (June 3, 2024)
  • K233531 — OIC FLEX-FIX™ System (February 2, 2024)