QJD · Class II · 21 CFR 888.3041

FDA Product Code QJD: Absorbable Metallic Bone Fixation Fastener

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.

Leading manufacturers include Bioretec, Ltd..

1
Total
0
Cleared
329d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Absorbable Metallic Bone Fixation Fastener Devices (Product Code QJD)

1 devices
1–1 of 1
Not Cleared Mar 29, 2023
RemeOs™ Screw LAG Solid
DEN220030
Bioretec, Ltd.
Orthopedic · 329d

About Product Code QJD - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QJD since 2023, with 0 receiving FDA clearance (average review time: 329 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QJD devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →