Home / 510(k) Clearances / K121413

510(k) K121413

CROSSFIX II MEMISCAL REPAIR DEVICE by Cayenne Medical, Inc. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2012
Date Received
May 11, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Cayenne Medical, Inc.

  • K192428 — AFX Femoral Implant with Inserter (October 5, 2019)
  • 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)

Other clearances for product code GAT

  • K254188 — Meniscus Versaflex (February 19, 2026)
  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)
  • K234079 — HyperSuture Extension Line (May 10, 2024)
  • K231163 — HS Fiber Sutures (January 5, 2024)
  • K230311 — HyperSuture (November 24, 2023)