Innovasive Devices Intratunnel Tibial Fixation Fastener

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K983560 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Y-Knot Suture Clip

  Class II

  FDA 510(k) K973313 Active Cleared 1 Dec 1997

• Bioroc Ez Suture Bone Fastener

  Class II

  FDA 510(k) K973381 Active Cleared 18 Feb 1998

• Innovasive Tibial Fastener

  Class II

  FDA 510(k) K983056 Active Cleared 13 Oct 1998

• Rc Tack

  Class II

  FDA 510(k) K992377 Active Cleared 8 Oct 1999

• Innovasive 2.3mm Roc Xs Suture Bone Fastener

  Class II

  FDA 510(k) K972438 Active Cleared 26 Sep 1997

• Innovasive 2.3mm Roc Ez Suture Bone Fastener

  Class II

  FDA 510(k) K972356 Active Cleared 26 Aug 1997

See all devices from Innovasive Devices, Inc. →

• What is the Innovasive Devices Intratunnel Tibial Fixation Fastener used for?

  It is used to secure grafts or tissues within a tibial tunnel during orthopedic surgical fixation procedures, providing stable internal fixation to support healing.

• Is the Innovasive Devices Intratunnel Tibial Fixation Fastener supplied sterile and for single use only?

  Yes, the device is supplied as a single-use implant, meaning it is intended for one procedure only and should not be reprocessed or reused to ensure patient safety and device integrity.

• What regulatory pathway was used for the Innovasive Devices Intratunnel Tibial Fixation Fastener?

  The device received FDA 510(k) clearance through the traditional pathway, demonstrating substantial equivalence to a predicate device under product code MBI for orthopedic fixation.