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FDA 510(k)

STATIC CRANIOPLASTY ORTHOSIS

K-Number: K063098 · 2007-04-11

ApplicantBoston Brace Intl., Inc.
Decision Date2007-04-11
Product CodeOAN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STATIC CRANIOPLASTY ORTHOSIS is the device name listed in this FDA 510(k) record. The listed applicant is Boston Brace Intl., Inc.. It received FDA 510(k) clearance on 2007-04-11 under 510(k) number K063098. The device is classified under product code OAN. 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 2007-04-11. The listed applicant is Boston Brace Intl., Inc.. The 510(k) number is K063098.

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

STATIC CRANIOPLASTY ORTHOSIS received FDA 510(k) clearance on 2007-04-11, under 510(k) number K063098.

Who is the listed applicant for STATIC CRANIOPLASTY ORTHOSIS?

The FDA 510(k) record lists Boston Brace Intl., Inc. 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 OAN.

Related Clinical Trials

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Other records listing Boston Brace Intl., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K111609BOSTON BANDK072862BOSTON-BAND CRANIAL REMODLING ORTHOSIS

Related Devices (Code: OAN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K244056DOC Band 3DCranial Technologies, Inc.K240466STARband 3DOrthomerica Products, Inc.K211376STARbandOrthomerica Products, Inc.K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.K161138St. Louis BandOrthomerica Products, Inc.

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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