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510(k) K221468

Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants by Acuitive Technologies, Inc. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2023
Date Received
May 20, 2022
Clearance Type
Traditional
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 Acuitive Technologies, Inc.

  • K240450 — Citrepore™ (November 6, 2024)
  • K232592 — CITRELOCK® DUO (September 20, 2023)
  • K220833 — Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Ci (November 4, 2022)
  • K210239 — CITRESPLINE and CITRELOCK ACL Implants (February 24, 2021)
  • K203334 — The Citrefix Knotless Suture Anchor (February 5, 2021)
  • K200725 — Citregen Tendon Interference Screw and Citrelock (October 7, 2020)

Other clearances for product code MAI

  • K260294 — SF Push-in Anchor (March 27, 2026)
  • 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)