DeviceClearance

Product code QJD— Orthopedic

RemeOs Screw LAG Solid

Classification name
Absorbable Metallic Bone Fixation Fastener
Device class
Class 2
Regulation
21 CFR 888.3041
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

“An absorbable metallic bone fixation fastener is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis. The device is designed to fully absorb after steosynthesis is achieved.”

— U.S. Food and Drug Administration, device classification record for product code QJD under 21 CFR 888.3041, via openFDA

Market context for product code QJD

FDA has cleared 1 device under product code QJD, all in 2023, 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 QJD

Recent clearances under product code QJD

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