Titanodont Subcortical Implant with Porocoat
FDA 510(k) K871219 · Depuy, Inc.
510(k) numberK871219
Submission
- Device name
- Titanodont Subcortical Implant with Porocoat
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- March 27, 1987
- Decision date
- June 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Titanodont Subcortical Implant with Porocoat cleared by the FDA?
Titanodont Subcortical Implant with Porocoat (K871219) received a 510(k) decision of Substantially Equivalent on June 4, 1987, 69 days after the submission was received.
What is the product code of K871219?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.