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510(k) K231033

CEPTRE® Knotted UHMWPE Suture PEEK Anchor by Healthium Medtech Limited — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2024
Date Received
April 11, 2023
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

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  • K231404 — T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S (August 4, 2023)
  • K223889 — Stativ® Knotted UHMWPE Suture Anchor (March 22, 2023)

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