FDA 510(k) K143659, Equinoxe Mega Prosthesis, by Exactech, Inc.
FDA 510(k) K143659, Equinoxe Mega Prosthesis, by Exactech, Inc.
Device Classification Name: Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number: K143659
Device Name: Equinoxe Mega Prosthesis
Applicant: Exactech, Inc.
Regulation Number: 888.365
Classification Product Code: KWT
Date Received: 2014-12-23
Decision Date: 2015-04-09
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic
Total number of pages: 775
Fully redacted pages: 538
Content pages: 237
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