Dynnail, 12mm, Locking Screw, 4.6 Mm, Deployment Frame, Dynnail, Models 1200-01-1222, 1200-02-46XX, 2200-01-0000

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K101934 ↗

FDA Product Code

HSB

Models / Variants

1200-01-1222

1200-02-46XX

2200-01-0000

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Shapeloc-Cl (Cruciate Ligament) Soft Tissie Fastner, Shapeloc-St (Tenodesis) Soft Tissue Fastner

  Class II

  FDA 510(k) K101808 Active Cleared 8 Nov 2010

• Wedgeloc 180X (Standard and Cortical) Suture Anchor With Opti-Fiber Sutures

  Class II

  FDA 510(k) K092914 Active Cleared 9 Dec 2009

• Wedgeloc 180X Standard Suture Anchor with Opti Fiber Sutures, Model 1000-01 Tab Varying Diameters,

  Class II

  FDA 510(k) K091202 Active Cleared 16 Sep 2009

• Exoshape (Tm) Interference Fixation Device Model 1100-00-Xxxx (Varies by Size)

  Class II

  FDA 510(k) K111471 Active Cleared 10 Jun 2011

• Wedgeloc Suture Anchor with Opti-Fiber Sutures, Model 1000-01-055

  Class II

  FDA 510(k) K083792 Active Cleared 25 Mar 2009