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