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510(k) DEN220012

Tornier Pyrocarbon Humeral Head by Tornier S.A.S. — Product Code QKW

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
December 16, 2022
Date Received
February 8, 2022
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
Device Class
Class II
Regulation Number
888.3695
Review Panel
OR
Submission Type

A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty.

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