Stabilizer Soft Tissue Anchor, 8mm (TA1008 +5 more) - Suture Organizer

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K964927 ↗

FDA Product Code

MBI

Models / Variants

TA1008

Anchor Inserter

Suture Organizer

8mm Model AI1008

Stabilizer Drill

8

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Stabilizer Soft Tissue Anchor Model Number TA1005, TA1008, Anchor Inserter/Suture Organizer Model Numbers AI1005, AI1008

  Class II

  FDA 510(k) K965111 Active Cleared 18 Feb 1997

• Stabilizer Soft Tissue Anchor 5mm Model TA1005, Anchor Inserter/Suture Organizer 5mm AI1005, Stabilizer Drill 5mm Nonste

  Class I

  FDA 510(k) K973031 Active Cleared 3 Nov 1997

• Stabilizer Soft Tissue Anchor, 5 and 8mm; Anchor Inserter, 5 and 8mm; Stabilizer Drill, 5 and 8mm, Nonsterile; Stabilize

  Class II

  FDA 510(k) K984200 Active Cleared 21 Jan 1999