Salto XT, Salto Talaris

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

Tornier SAS

The following data is part of a premarket notification filed by Tornier Sas with the FDA for Salto Xt, Salto Talaris.

Pre-market Notification Details

• Device ID: K153452
• 510k Number: K153452
• Device Name: Salto XT, Salto Talaris
• Classification: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
• Applicant: Tornier SAS 161 Rue Lavoisier Montbonnot St. Martin, FR 38330
• Contact: Séverine Bonneton
• Correspondent: Séverine Bonneton; Tornier SAS 161 Rue Lavoisier Montbonnot St. Martin, FR 38330
• Product Code: HSN
• CFR Regulation Number: 888.3110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-30
• Decision Date: 2016-08-11
• Summary: summary

NIH GUDID Devices

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