DeviceClearance

Product code QAC— Orthopedic

OGmend Implant System

Classification name
Screw Sleeve Bone Fixation Device
Device class
Class 2
Regulation
21 CFR 888.3043
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QAC under 21 CFR 888.3043, via openFDA

Market context for product code QAC

FDA has cleared 1 device under product code QAC, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QAC

Recent clearances under product code QAC

Data sourced from openFDA. This site is unofficial and independent of the FDA.