510(k) K242596

Versalock Mini and Micro Plating System by GM Dos Reis Industria e Comercio Ltda. — Product Code HRS

K242596 is an FDA 510(k) premarket notification submitted by GM Dos Reis Industria e Comercio Ltda. for the device "Versalock Mini and Micro Plating System". The FDA issued a decision of Substantially Equivalent on November 21, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. GM Dos Reis Industria e Comercio Ltda. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2024
Date Received
August 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type