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