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510(k) K182609

Delphos Implants Rigid Fixation System by Delphos Implants - Ind.Com. Importacao E Exportacao DE — Product Code JEY

K182609 is an FDA 510(k) premarket notification submitted by Delphos Implants - Ind.Com. Importacao E Exportacao DE for the device "Delphos Implants Rigid Fixation System". The FDA issued a decision of Substantially Equivalent on Mar 29, 2019. The device falls under product code JEY (Plate, Bone), a Class II device regulated under 21 CFR 872.4760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 29, 2019
Date Received
Sep 21, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type
510(k)

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FDA data resources