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FDA 510(k)

CRANIAL MOLDING ORTHOSIS

K-Number: K010273 · 2001-04-25

ApplicantOrthotic Solutions, Inc.
Decision Date2001-04-25
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIAL MOLDING ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Orthotic Solutions, Inc.. It received FDA 510(k) clearance on 2001-04-25 under 510(k) number K010273. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRANIAL MOLDING ORTHOSIS?

CRANIAL MOLDING ORTHOSIS is a medical device that received FDA 510(k) clearance on 2001-04-25. The listed applicant is Orthotic Solutions, Inc.. The 510(k) number is K010273.

When did CRANIAL MOLDING ORTHOSIS receive FDA 510(k) clearance?

CRANIAL MOLDING ORTHOSIS received FDA 510(k) clearance on 2001-04-25, under 510(k) number K010273.

Who is the listed applicant for CRANIAL MOLDING ORTHOSIS?

The FDA 510(k) record lists Orthotic Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRANIAL MOLDING ORTHOSIS?

The FDA product code for CRANIAL MOLDING ORTHOSIS is MVA.

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Related Devices (Code: MVA)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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