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510(k) K133036

APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS by Amendia, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2014
Date Received
September 26, 2013
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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  • K152972 — Amendia Stand-Alone Cervical System (January 14, 2016)
  • K151310 — Amendia Interbody Fusion Devices (January 6, 2016)
  • K152460 — Rectangular Corpectomy Cage (December 22, 2015)
  • K152455 — Amendia Cervical Plate System (October 15, 2015)
  • K151322 — Amendia Interbody Fusion Devices (September 10, 2015)

Other clearances for product code MBI

  • K251750 — Trax EX Anchor (March 12, 2026)
  • K253693 — Strut Suture; No-Tie Button (March 11, 2026)
  • K260405 — FiberTape Button (March 9, 2026)
  • K253538 — TeKBrace Knotless Anchor (March 6, 2026)
  • K254306 — Aevumed FENIX Suture Anchor (March 4, 2026)
  • K254229 — Arthrex Nano FiberTak Suture Anchor (March 2, 2026)
  • K253695 — LigaMend (February 27, 2026)
  • K253763 — Y-Knotless™ Flex Anchors (January 29, 2026)
  • K260004 — Aevumed PROTEKT Suture Anchor (January 28, 2026)
  • K253618 — QuadLock™ Fixation System (January 6, 2026)