NEOVIEW Plating System— 510(k) K160995

Clearance details

Applicant

In2bones Sas

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2016-04-08

Decision date

2016-06-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ecully, FR

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• K231699 — QUANTUM® Patient Specific Instrumentation (PSI) System2024-04-23
• K230313 — QUANTUM Patient Specific Instrumentation (PSI) System2023-04-06
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• K191380 — Quantum® Total Ankle Prosthesis2020-01-29
• K173811 — TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System2018-03-15

Death

27

Injury

10,340

Malfunction

3,328

Total

13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• 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·In2Bones, SAS·20170713
• 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·In2Bones, SAS·20161219
• 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·In2Bones, SAS·20161219
• 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·In2Bones, SAS·20161219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160995.