Biosorbfx Tack and Biosorbpdx Tack Bioabsorbable Fixation Fastener, Used with Plates

No FDA recalls found in the data synced 9 Oct 2026.

510(k) Number

K003756 ↗

FDA Product Code

JEY

Device Class

Class II

Regulation

21 CFR Part 872.4760

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Biosorbfx 1.5/2.0 Bioabsorbable Fixation System

  Class II

  FDA 510(k) K982139 Active Cleared 15 Sep 1998

• Plla Pin

  Class II

  FDA 510(k) K010983 Active Cleared 13 Jun 2001

• Biosorbpdx Bioabsorbable Fixation System

  Class II

  FDA 510(k) K000836 Active Cleared 8 Jun 2000

• Nugen Fx Screw

  Class II

  FDA 510(k) K023022 Active Cleared 4 Oct 2002

• Contour Meniscus Arrow, Models 541110, 541113, and 541116

  Class II

  FDA 510(k) K012334 Active Cleared 19 Sep 2001

• Meniscus Arrow Sheath #CN1000A; Smartscrew Acl Sheath #SSA2000A

  Class II

  FDA 510(k) K010554 Active Cleared 25 May 2001

See all devices from Bionx Implants, Inc. →