Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)— 510(k) K253447

Clearance details

Applicant

Orthocon, Inc.

Product code

Code GXR

Device class

Class 2

Regulation

21 CFR 882.5250

Advisory panel

Neurology

Date received

2025-10-02

Decision date

2026-03-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Stamford, CT, US

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