Home / 510(k) Clearances / K121890

510(k) K121890

GENESYS PRESSFT SUTURE ANCHOR by Linvatec Corporation D/B/A Conmed Linvatec — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2012
Date Received
June 28, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Linvatec Corporation D/B/A Conmed Linvatec

  • K131035 — Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM (July 2, 2013)
  • K130497 — D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION (March 29, 2013)
  • K112965 — NANO SUTURE ANCHOR (November 2, 2011)

Other clearances for product code MAI

  • K254055 — OSSIOfiber® Suture Anchor (February 24, 2026)
  • K251680 — Biosteon® Screw (February 17, 2026)
  • K252946 — BioBrace® Extra-Articular Ligament Augmentation Kit (October 15, 2025)
  • K252022 — OSSIOfiber® Interference Screw (August 19, 2025)
  • K251309 — OSSIOfiber® Suture Anchor (May 27, 2025)
  • K250544 — Knotilus+ Biocomposite Knotless Anchor (May 23, 2025)
  • K250528 — Stryker AlphaVent™ Knotless SP Biocomposite Anchor (May 21, 2025)
  • K243760 — OSSIOfiber® Suture Anchor 2.5-3.5 mm (April 3, 2025)
  • K250526 — Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor (March 14, 2025)
  • K243790 — GRYPHON™ X Anchor; HEALIX TRANSTEND™ Anchor (February 5, 2025)