510(k) DEN180065

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

May 1, 2020

Date Received

December 13, 2018

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Screw Sleeve Bone Fixation Device

Device Class

Class II

Regulation Number

888.3043

Review Panel

OR

Submission Type

A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.