Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BOSTON-BAND CRANIAL REMODLING ORTHOSIS

K-Number: K072862 · 2008-01-22

ApplicantBoston Brace Intl., Inc.
Decision Date2008-01-22
Product CodeOAN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BOSTON-BAND CRANIAL REMODLING 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 2008-01-22 under 510(k) number K072862. 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 BOSTON-BAND CRANIAL REMODLING ORTHOSIS?

BOSTON-BAND CRANIAL REMODLING ORTHOSIS is a medical device that received FDA 510(k) clearance on 2008-01-22. The listed applicant is Boston Brace Intl., Inc.. The 510(k) number is K072862.

When did BOSTON-BAND CRANIAL REMODLING ORTHOSIS receive FDA 510(k) clearance?

BOSTON-BAND CRANIAL REMODLING ORTHOSIS received FDA 510(k) clearance on 2008-01-22, under 510(k) number K072862.

Who is the listed applicant for BOSTON-BAND CRANIAL REMODLING 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 BOSTON-BAND CRANIAL REMODLING ORTHOSIS?

The FDA product code for BOSTON-BAND CRANIAL REMODLING ORTHOSIS is OAN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 BANDK063098STATIC CRANIOPLASTY 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

View on FDA Database →

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

↑