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510(k) K142230

Apollo Suture Anchor System and Titan Screws by Valeris Medical — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2014
Date Received
August 13, 2014
Clearance Type
Special
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 Valeris Medical

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  • K152255 — BoneCam Suture Anchors (November 16, 2015)

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  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
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