DRG Titanium Bone Plate
FDA 510(k) K990920 · Doctor'S Research Group, Inc.
510(k) numberK990920
Submission
- Device name
- DRG Titanium Bone Plate
- Applicant
- Doctor'S Research Group, Inc.
Wolcott, CT, US - Received
- March 18, 1999
- Decision date
- June 10, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was DRG Titanium Bone Plate cleared by the FDA?
DRG Titanium Bone Plate (K990920) received a 510(k) decision of Substantially Equivalent on June 10, 1999, 84 days after the submission was received.
What is the product code of K990920?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.