Inion CPS 2.0 Orthognathic Plate
FDA 510(k) K013039 · Inion , Ltd.
510(k) numberK013039
Submission
- Device name
- Inion CPS 2.0 Orthognathic Plate
- Applicant
- Inion , Ltd.
Tampere, FI - Received
- September 10, 2001
- Decision date
- October 5, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Inion CPS 2.0 Orthognathic Plate cleared by the FDA?
Inion CPS 2.0 Orthognathic Plate (K013039) received a 510(k) decision of Substantially Equivalent on October 5, 2001, 25 days after the submission was received.
What is the product code of K013039?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.