QAC · Class II · 21 CFR 888.3043

FDA Product Code QAC: Screw Sleeve Bone Fixation Device

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.

1
Total
0
Cleared
505d
Avg days
2020
Since

FDA 510(k) Cleared Screw Sleeve Bone Fixation Device Devices (Product Code QAC)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code QAC - Regulatory Context