In-Fast Bone Screw System/in-Fast Bone Screw Inserter/in-Fast Bone Screw

• • Terminated Z-1235-2008 FDA Unclassified (pre-2012) ·initiated 28 Jan 2008

  Missing part: The units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may contain only one bone screw, but should contain two as indicated on the labeling. Two screws are required to complete the procedure. The missing screw will result in the inability to complete the procedure as expected if there are no additional screws readily available.

510(k) Number

K970292 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Microtac-Bone Anchor System

  Class II

  FDA 510(k) K990160 Active Cleared 16 Feb 1999

• In-Sling

  Class II

  FDA 510(k) K972651 Active Cleared 19 Sep 1997

• Triangle Sling

  Class II

  FDA 510(k) K980482 Active Cleared 27 Mar 1998

• Influence Clip System

  Class II

  FDA 510(k) K981631 Active Cleared 28 Jul 1998

• Stapletac Bone Anchor System

  Class II

  FDA 510(k) K992277 Active Cleared 30 Jul 1999

• Repose Bone Screw System

  Class II

  FDA 510(k) K981677 Active Cleared 27 Aug 1999

See all devices from Influence, Inc. →