Argulated Locking Plates
FDA 510(k) K143338 · Osteomed LP
510(k) numberK143338
Submission
- Device name
- Argulated Locking Plates
- Applicant
- Osteomed LP
Addison, TX, US - Received
- November 20, 2014
- Decision date
- April 1, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Argulated Locking Plates cleared by the FDA?
Argulated Locking Plates (K143338) received a 510(k) decision of Substantially Equivalent on April 1, 2015, 132 days after the submission was received.
What is the product code of K143338?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.