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FDA 510(k)

BOSTON BAND

K-Number: K111609 · 2011-08-22

ApplicantBoston Brace Intl., Inc.
Decision Date2011-08-22
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BOSTON BAND 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 2011-08-22 under 510(k) number K111609. 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 BOSTON BAND?

BOSTON BAND is a medical device that received FDA 510(k) clearance on 2011-08-22. The listed applicant is Boston Brace Intl., Inc.. The 510(k) number is K111609.

When did BOSTON BAND receive FDA 510(k) clearance?

BOSTON BAND received FDA 510(k) clearance on 2011-08-22, under 510(k) number K111609.

Who is the listed applicant for BOSTON BAND?

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 BOSTON BAND?

The FDA product code for BOSTON BAND is MVA.

Related Clinical Trials

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.

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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.

K072862BOSTON-BAND CRANIAL REMODLING ORTHOSISK063098STATIC CRANIOPLASTY ORTHOSIS

Related Devices (Code: MVA)

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.

K241957Talee, Talee PostOpInvent Medical USA, LLCK230444Talee, Talee PostOpInvent Medical USA, LLCK223238STARband 3DOrthomerica Products, Inc.K220681Talee, Talee PostOPInvent Medical USA, LLCK203134Hanger Cranial Band 3DSymbion Logistics, LLCK213587MyCRO BandOtto Bock Healthcare LP

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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