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510(k) K192428

AFX Femoral Implant with Inserter by Cayenne Medical — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2019
Date Received
September 5, 2019
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 Cayenne Medical

  • K180274 — Ventix Link Knotless Anchor with Inserter (March 21, 2018)
  • K172186 — BioWick X Implant with Driver (October 16, 2017)
  • K161033 — AFX™ Femoral Implant With Inserter (August 3, 2016)
  • K151068 — SureLock W Suture Anchor (July 24, 2015)
  • K143473 — Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needl (March 25, 2015)
  • K143392 — Quattro Bolt Tenodesis Screw (January 23, 2015)
  • K132867 — SURELOCK ALL-SUTURE ANCHOR WITH INSERTER, 1.4MM, SURELOCK ALL-SUTURE ANCHOR WITH (December 30, 2013)
  • K131325 — QUATTRO GL SUTURE ANCHOR (August 16, 2013)
  • K122314 — QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY (October 31, 2012)
  • K122463 — APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH I (October 11, 2012)

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