FDA 510(k) K240062, ARVIS® Shoulder, by Insight Medical Systems, Inc.

FDA 510(k) K240062, ARVIS® Shoulder, by Insight Medical Systems, Inc.

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Device Classification Name: Orthopedic Stereotaxic Instrument
510(k) Number: K240062
Device Name: ARVIS® Shoulder
Applicant: Insight Medical Systems, Inc.
Regulation Number: 882.4560
Classification Product Code: OLO
Date Received: 01/09/2024
Decision Date: 04/29/2024
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
510k Review Panel: Orthopedic

Total number of pages: 2,693
Fully redacted pages: 2,327
Content pages: 366

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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