In2bones Sas

• HWC — Orthopedic6 devices
• HSN — Orthopedic4 devices
• JDR — Orthopedic3 devices
• HRS — Orthopedic2 devices
• HTY — Orthopedic2 devices
• HSB — Orthopedic1 device

• Z-1319-2024 — I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175Class II·Ongoing·2024-01-26
• Z-1320-2024 — I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180Class II·Ongoing·2024-01-26
• Z-1283-2021 — In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.Class II·Terminated·2021-02-09
• Z-2869-2017 — Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 (f) DRP 0.27 - 18 mm, REF W27 ST018 The NEOVIEW(R) Plating System is intended for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius. It is composed of a NEOVIEW" plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomyClass II·Terminated·2017-07-13
• Z-0953-2017 — NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radiusClass II·Terminated·2016-12-19
• Z-0954-2017 — NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radiusClass II·Terminated·2016-12-19
• Z-0952-2017 — SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radiusClass II·Terminated·2016-12-19
• Z-0397-2016 — IBS - Osteosynthesis screws for bone fixation Model S25 ST014.Class II·Terminated·2015-11-18
• Z-1318-2015 — DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only. Interphalangeal implant.Class II·Terminated·2015-03-09
• Z-1319-2015 — DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only. Interphalangeal implant.Class II·Terminated·2015-03-09

Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.

• K231699 — QUANTUM® Patient Specific Instrumentation (PSI) SystemCode HSN·2024-04-23
• K230313 — QUANTUM Patient Specific Instrumentation (PSI) SystemCode HSN·2023-04-06
• K211883 — QUANTUM® Patient Specific Instrumentation (PSI) SystemCode HSN·2021-08-11
• K191380 — Quantum® Total Ankle ProsthesisCode HSN·2020-01-29
• K173811 — TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemCode HSB·2018-03-15
• K173616 — DIP Arthrodesis SystemCode HTY·2018-01-19
• K170688 — PITStop® implantCode HWC·2017-11-28
• K173121 — Ankle Fusion Plating SystemCode HRS·2017-11-28
• K170594 — I.B.S. osteosynthesis screwsCode HWC·2017-05-10
• K160174 — I.B.S. 2.0 Osteosynthesis screwCode HWC·2016-10-06
• K160995 — NEOVIEW Plating SystemCode HRS·2016-06-10
• K153770 — OS2(R)-VP Varisation StapleCode JDR·2016-03-21
• K153395 — OS2-C Compression StapleCode JDR·2016-02-18
• K153204 — In2Bones Kirschner wireCode HTY·2016-02-01
• K143323 — OS2-V Varisation StapleCode JDR·2015-02-26
• K132912 — DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANTCode HWC·2014-07-30
• K131920 — STABILIZATION SCREWCode HWC·2014-05-01
• K132911 — I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREWCode HWC·2014-04-04