Cranial Molding Orthosis

by Orthotic Solutions, Inc.

510(k) K010273

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K010273↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK010273	Date25 Apr 2001Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K010273
FDA Product Code: MVA

Device Class: Class II
Regulation: 21 CFR Part 882.5970
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cranial Molding Orthosis is a medical device designed to apply pressure to prominent regions of an infant's cranium. It is intended to improve cranial symmetry and shape in infants aged 3 to 18 months who have moderate to severe nonsynostotic positional plagiocephaly.

This device is classified under regulation number 882.5970 and has received FDA 510(k) clearance under K010273. It functions as an external brace, such as a helmet or headband, to assist in the correction of asymmetrical head shapes.