QUANTUM® Patient Specific Instrumentation (PSI) System

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

In2Bones SAS

The following data is part of a premarket notification filed by In2bones Sas with the FDA for Quantum® Patient Specific Instrumentation (psi) System.

Pre-market Notification Details

• Device ID: K211883
• 510k Number: K211883
• Device Name: QUANTUM® Patient Specific Instrumentation (PSI) System
• Classification: Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
• Applicant: In2Bones SAS 26 Chemin Du Petit Bois Ecully, FR 69130
• Contact: Morgane Grenier
• Correspondent: Christine Scifert; In2Bones USA 6600 Poplar Ave, Suite 115 Memphis, TN 38119
• Product Code: HSN
• CFR Regulation Number: 888.3110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-06-21
• Decision Date: 2021-08-11