FDA 510(k) K181420, Aequalis Flex Revive Shoulder System, by Tornier, Inc.

FDA 510(k) K181420, Aequalis Flex Revive Shoulder System, by Tornier, Inc.

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Device Classification Name: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number: K181420
Device Name: Aequalis Flex Revive Shoulder System
Applicant: Tornier, Inc.
Regulation Number: 888.366
Classification Product Code: KWS
Date Received: 2018-05-31
Decision Date: 2018-09-20
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic

Total number of pages: 1,210
Fully redacted pages: 892
Content pages: 318

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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