FDA 510(k) K212237, 3D-Cut, by 3D-Side S.A.
FDA 510(k) K212237, 3D-Cut, by 3D-Side S.A.
Device Classification Name: Orthopaedic Surgical Planning And Instrument Guides
510(k) Number: K212237
Device Name: 3D-Cut
Applicant: 3D-Side S.A.
Regulation Number: 888.3030
Classification Product Code: PBF
Date Received: 07/19/2021
Decision Date: 11/29/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic
Total number of pages: 2,130
Fully redacted pages: 1,616
Content pages: 514
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.
View full details