In2Bones, SAS
Summary
- Total Recalls
- 10
- 510(k) Clearances
- 18
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1319-2024 | Class II | I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 | January 26, 2024 |
| Z-1320-2024 | Class II | I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 | January 26, 2024 |
| Z-1283-2021 | Class II | In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percut | February 9, 2021 |
| Z-2869-2017 | Class II | Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.2 | July 13, 2017 |
| Z-0954-2017 | Class II | NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixati | December 19, 2016 |
| Z-0952-2017 | Class II | SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ec | December 19, 2016 |
| Z-0953-2017 | Class II | NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France | December 19, 2016 |
| Z-0397-2016 | Class II | IBS - Osteosynthesis screws for bone fixation Model S25 ST014. | November 18, 2015 |
| Z-1318-2015 | Class II | DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant. | March 9, 2015 |
| Z-1319-2015 | Class II | DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant. | March 9, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K231699 | QUANTUM® Patient Specific Instrumentation (PSI) System | April 23, 2024 |
| K230313 | QUANTUM Patient Specific Instrumentation (PSI) System | April 6, 2023 |
| K211883 | QUANTUM® Patient Specific Instrumentation (PSI) System | August 11, 2021 |
| K191380 | Quantum® Total Ankle Prosthesis | January 29, 2020 |
| K173811 | TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System | March 15, 2018 |
| K173616 | DIP Arthrodesis System | January 19, 2018 |
| K173121 | Ankle Fusion Plating System | November 28, 2017 |
| K170688 | PITStop® implant | November 28, 2017 |
| K170594 | I.B.S. osteosynthesis screws | May 10, 2017 |
| K160174 | I.B.S. 2.0 Osteosynthesis screw | October 6, 2016 |
| K160995 | NEOVIEW Plating System | June 10, 2016 |
| K153770 | OS2(R)-VP Varisation Staple | March 21, 2016 |
| K153395 | OS2-C Compression Staple | February 18, 2016 |
| K153204 | In2Bones Kirschner wire | February 1, 2016 |
| K143323 | OS2-V Varisation Staple | February 26, 2015 |
| K132912 | DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT | July 30, 2014 |
| K131920 | STABILIZATION SCREW | May 1, 2014 |
| K132911 | I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW | April 4, 2014 |