Peba Anchor/Suture Combination

• • Terminated Z-1273-2020 FDA Class II ·initiated 30 Dec 2019

  Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.

510(k) Number

K972326 ↗

FDA Product Code

MBI

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Polymer Threaded Anchor / Suture Combination

  Class II

  FDA 510(k) K982963 Active Cleared 20 Nov 1998

• Threaded Fixation Pin (K963433)

  Class II

  FDA 510(k) K963433 Active Cleared 6 Nov 1996

• Sb Anchor

  Class II

  FDA 510(k) K942889 Active Cleared 25 Aug 1995

• Polymer Obl Sb Anchor / Suture Combination

  Class II

  FDA 510(k) K982996 Active Cleared 4 Mar 1999

• Bioaction Low Profile Screw System

  Class II

  FDA 510(k) K922788 Active Cleared 12 Mar 1993

• Xanchor Suture Attachment Device

  Class II

  FDA 510(k) K932041 Active Cleared 12 Aug 1994

See all devices from Orthopaedic Biosystems, Ltd. →