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FDA 510(k)

STATIC CRANIOPLASTY ORTHOSIS

K-Number: K020448 · 2002-04-12

ApplicantEastern Cranial Affiliates
Decision Date2002-04-12
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STATIC CRANIOPLASTY ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Eastern Cranial Affiliates. It received FDA 510(k) clearance on 2002-04-12 under 510(k) number K020448. 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 STATIC CRANIOPLASTY ORTHOSIS?

STATIC CRANIOPLASTY ORTHOSIS is a medical device that received FDA 510(k) clearance on 2002-04-12. The listed applicant is Eastern Cranial Affiliates. The 510(k) number is K020448.

When did STATIC CRANIOPLASTY ORTHOSIS receive FDA 510(k) clearance?

STATIC CRANIOPLASTY ORTHOSIS received FDA 510(k) clearance on 2002-04-12, under 510(k) number K020448.

Who is the listed applicant for STATIC CRANIOPLASTY ORTHOSIS?

The FDA 510(k) record lists Eastern Cranial Affiliates as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STATIC CRANIOPLASTY ORTHOSIS?

The FDA product code for STATIC CRANIOPLASTY 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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