QUANTUM® Patient Specific Instrumentation (PSI) System
In2bones Sas
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010470577 | 3010470577 | In2Bones SAS | 1 | N | 2026-01-01 | Immeuble Sequoia 3 97 Allee Alexandre Borodine Saint-Priest Rhone FR 69800 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 171441 | 2063323435 | K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | HSN | 2021-08-11 |
| 171441 | 1290409291 | K191380 | Quantum® Total Ankle Prosthesis | HSN | 2020-01-29 |
| 171441 | 1423543036 | K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | HSB | 2018-03-15 |
| 171441 | 1219441197 | K173616 | DIP Arthrodesis System | HTY | 2018-01-19 |
| 171441 | 1460339703 | K173121 | Ankle Fusion Plating System | HRS | 2017-11-28 |
| 171441 | 1591563125 | K170688 | PITStop® implant | HWC | 2017-11-28 |
| 171441 | 1637375684 | K170594 | I.B.S. osteosynthesis screws | HWC | 2017-05-10 |
| 171441 | 1677322604 | K160995 | NEOVIEW Plating System | HRS | 2016-06-10 |
| 171441 | 1561710300 | K160174 | I.B.S. 2.0 Osteosynthesis screw | HWC | 2016-10-06 |
| 171441 | 1971725071 | K153770 | OS2(R)-VP Varisation Staple | JDR | 2016-03-21 |
| 171441 | 1217102198 | K153395 | OS2-C Compression Staple | JDR | 2016-02-18 |
| 171441 | 1389612364 | K153204 | In2Bones Kirschner wire | HTY | 2016-02-01 |
| 171441 | 1240024553 | K143323 | OS2-V Varisation Staple | JDR | 2015-02-26 |
| 171441 | 1856580947 | K132912 | DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT | HWC | 2014-07-30 |
| 171441 | 1566896568 | K132911 | I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW | HWC | 2014-04-04 |
| 171441 | 1684202343 | K131920 | STABILIZATION SCREW | HWC | 2014-05-01 |
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