FDA 510(k) K220628, LINK Endo-Model EVO Knee System, by Waldemar Link GmbH & Co. KG

FDA 510(k) K220628, LINK Endo-Model EVO Knee System, by Waldemar Link GmbH & Co. KG

Regular price $2,690.66 USD
Regular price Sale price $2,690.66 USD
Sale Sold out

Device Classification Name: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number: K220628
Device Name: LINK Endo-Model EVO Knee System
Applicant: Waldemar Link GmbH & Co. KG
Regulation Number: 888.3510
Classification Product Code: KRO
Date Received: 03/04/2022
Decision Date: 05/03/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic

Total number of pages: 1,604
Fully redacted pages: 414
Content pages: 1,190

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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