BLUEPRINT™ Patient Specific Instrumentation

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Tornier SAS

The following data is part of a premarket notification filed by Tornier Sas with the FDA for Blueprint™ Patient Specific Instrumentation.

Pre-market Notification Details

• Device ID: K203315
• 510k Number: K203315
• Device Name: BLUEPRINT™ Patient Specific Instrumentation
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: Tornier SAS 161 Rue Lavoisier Montbonnot Saint Martin, FR 38330
• Contact: Aymen Azaiez
• Correspondent: Aymen Azaiez; Tornier SAS 161 Rue Lavoisier Montbonnot Saint Martin, FR 38330
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-11-10
• Decision Date: 2021-04-15