NEOVIEW Plating System

by In2Bones SAS

510(k) K160995

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

4 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160995↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK160995	Date10 Jun 2016Cleared	StatusActive
European Union	CE/MDR EUDAMED	Number—	Date—	StatusActive
European Union	CE/MDD EUDAMED	Number—	Date—	StatusActive

Official records

EUDAMED public site
FDA 510(k) database 510(k) number K160995

Across registries

2 registries list this device

FDA 510(k) K160995 decided 10 Jun 2016 Active
EUDAMED Active· +1 more in the status table

Recalls

4 recalls · FDA

- Terminated Z-2869-2017 FDA Class II initiated 13 Jul 2017
The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis
3 recalls, same reason
- Terminated Z-0953-2017 FDA Class II initiated 19 Dec 2016
- Terminated Z-0954-2017 FDA Class II initiated 19 Dec 2016
- Terminated Z-0952-2017 FDA Class II initiated 19 Dec 2016
Dimensional non-conformity of the thread on the screw head.

Timeline

5 dated events

10 Jun 2016 Cleared FDA 510(k) K160995
19 Dec 2016 Recall initiated FDA recalls Z-0953-2017
19 Dec 2016 Recall initiated FDA recalls Z-0954-2017
19 Dec 2016 Recall initiated FDA recalls Z-0952-2017
13 Jul 2017 Recall initiated FDA recalls Z-2869-2017

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR, CE/MDD Active
United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number: K160995
FDA product code: HRS

Device class: Class II
Regulation: 21 CFR Part 888.3030
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Neoview Plating System is a surgical orthopedic device designed for internal fixation of long bone fractures. It consists of plates and screws used to stabilize and support bone fragments during the healing process, ensuring proper alignment and structural integrity.

This system is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under the product code HRS and has received FDA 510(k) clearance, MDD, and MDR authorizations. The system is engineered for use in procedures requiring precise fixation, with components tailored for compatibility with standard orthopedic instrumentation.

Devices cleared under K160995

65 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K160995
		UDI-DI	Size and differences
NEOFIT P10 ST145 IN2BONES	P10 ST145 / P10 ST145	03760225712924	Single use: yes	No longer on the market
NEOFIT P10 ST235 IN2BONES	P10 ST235 / P10 ST235	03760225714515	Single use: yes	No longer on the market
NEOFIT P10 ST240 IN2BONES	P10 ST240 / P10 ST240	03760225712948	Single use: yes	No longer on the market
NEOFIT P10 ST245 IN2BONES	P10 ST245 / P10 ST245	03760225712955	Single use: yes	No longer on the market
NEOFIT® V27 ST010 IN2BONES	V27 ST010 / V27 ST010	03760225712672	Single use: yes	No longer on the market
NEOFIT® V27 ST012 IN2BONES	V27 ST012 / V27 ST012	03760225712689	Single use: yes	No longer on the market
NEOFIT® V27 ST014 IN2BONES	V27 ST014 / V27 ST014	03760225712696	Single use: yes	No longer on the market
NEOFIT® V27 ST016 IN2BONES	V27 ST016 / V27 ST016	03760225712702	Single use: yes	No longer on the market
NEOFIT® V27 ST018 IN2BONES	V27 ST018 / V27 ST018	03760225712719	Single use: yes	No longer on the market
NEOFIT® V27 ST020 IN2BONES	V27 ST020 / V27 ST020	03760225712726	Single use: yes	No longer on the market
NEOFIT® V27 ST110 IN2BONES	V27 ST110 / V27 ST110	03760225712733	Single use: yes	No longer on the market
NEOFIT® V27 ST112 IN2BONES	V27 ST112 / V27 ST112	03760225712740	Single use: yes	No longer on the market
NEOFIT® V27 ST116 IN2BONES	V27 ST116 / V27 ST116	03760225712764	Single use: yes	No longer on the market
NEOFIT® V27 ST118 IN2BONES	V27 ST118 / V27 ST118	03760225712771	Single use: yes	No longer on the market
NEOFIT® V27 ST120 IN2BONES	V27 ST120 / V27 ST120	03760225712788	Single use: yes	No longer on the market
NEOFIT® V30 ST010 IN2BONES	V30 ST010 / V30 ST010	03760225712795	Single use: yes	No longer on the market
NEOFIT® V30 ST012 IN2BONES	V30 ST012 / V30 ST012	03760225712801	Single use: yes	No longer on the market
NEOFIT® V30 ST014 IN2BONES	V30 ST014 / V30 ST014	03760225712818	Single use: yes	No longer on the market
NEOFIT® V30 ST018 IN2BONES	V30 ST018 / V30 ST018	03760225712832	Single use: yes	No longer on the market
NEOFIT® V30 ST020 IN2BONES	V30 ST020 / V30 ST020	03760225712849	Single use: yes	No longer on the market
NEOFIT® V30 ST110 IN2BONES	V30 ST110 / V30 ST110	03760225712856	Single use: yes	No longer on the market
NEOFIT® V30 ST112 IN2BONES	V30 ST112 / V30 ST112	03760225712863	Single use: yes	No longer on the market
NEOFIT® V30 ST116 IN2BONES	V30 ST116 / V30 ST116	03760225712887	Single use: yes	No longer on the market
NEOVIEW® P03 00071 IN2BONES	P03 00071 / P03 00071	03760225714997	Width 16.75 mm; Length 22.80 mm Single use: yes	On the market
NEOVIEW® P03 00081 IN2BONES	P03 00081 / P03 00081	03760225715000	Length 22.80 mm; Width 16.75 mm Single use: yes	On the market
NEOVIEW® P03 00121 IN2BONES	P03 00121 / P03 00121	03760225715888	Length 56.80 mm; Width 25.80 mm Single use: no	On the market
NEOVIEW® P30 SP110 IN2BONES	P30 SP110 / P30 SP110	03760225713532	Width 22.90 mm; Length 54.83 mm Single use: yes	On the market
NEOVIEW® P30 SP120 IN2BONES	P30 SP120 / P30 SP120	03760225713549	Length 54.83 mm; Width 25.90 mm Single use: yes	On the market
NEOVIEW® P30 SP210 IN2BONES	P30 SP210 / P30 SP210	03760225713556	Width 22.90 mm; Length 54.83 mm Single use: yes	On the market
NEOVIEW® P30 SP220 IN2BONES	P30 SP220 / P30 SP220	03760225713563	Length 54.83 mm; Width 25.90 mm Single use: yes	On the market
NEOVIEW® W27 ST010 IN2BONES	W27 ST010 / W27 ST010	03760225713570	Length 10 mm; Outer Diameter 2.7 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST012 IN2BONES	W27 ST012 / W27 ST012	03760225713587	Outer Diameter 2.7 mm; Length 12 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST014 IN2BONES	W27 ST014 / W27 ST014	03760225713594	Length 14 mm; Outer Diameter 2.7 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST016 IN2BONES	W27 ST016 / W27 ST016	03760225713600	Outer Diameter 2.7 mm; Length 16 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST018 IN2BONES	W27 ST018 / W27 ST018	03760225713617	Length 18 mm; Outer Diameter 2.7 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST020 IN2BONES	W27 ST020 / W27 ST020	03760225713624	Outer Diameter 2.7 mm; Length 20 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST022 IN2BONES	W27 ST022 / W27 ST022	03760225713631	Length 22 mm; Outer Diameter 2.7 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST024 IN2BONES	W27 ST024 / W27 ST024	03760225713648	Outer Diameter 2.7 mm; Length 24 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST026 IN2BONES	W27 ST026 / W27 ST026	03760225713655	Length 26 mm; Outer Diameter 2.7 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST028 IN2BONES	W27 ST028 / W27 ST028	03760225713662	Outer Diameter 2.7 mm; Length 28 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST030 IN2BONES	W27 ST030 / W27 ST030	03760225713679	Length 30 mm; Outer Diameter 2.7 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST110 IN2BONES	W27 ST110 / W27 ST110	03760225713686	Outer Diameter 2.7 mm; Length 10 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST112 IN2BONES	W27 ST112 / W27 ST112	03760225713693	Length 12 mm; Outer Diameter 2.7 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST116 IN2BONES	W27 ST116 / W27 ST116	03760225713716	Length 16 mm; Outer Diameter 2.7 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST120 IN2BONES	W27 ST120 / W27 ST120	03760225713730	Length 20 mm; Outer Diameter 2.7 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST122 IN2BONES	W27 ST122 / W27 ST122	03760225713747	Outer Diameter 2.7 mm; Length 22 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST126 IN2BONES	W27 ST126 / W27 ST126	03760225713761	Outer Diameter 2.7 mm; Length 26 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST128 IN2BONES	W27 ST128 / W27 ST128	03760225713778	Length 28 mm; Outer Diameter 2.7 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST130 IN2BONES	W27 ST130 / W27 ST130	03760225713785	Outer Diameter 2.7 mm; Length 30 mm Single use: yes	No longer on the market
NEOVIEW® W27 ST900 IN2BONES	W27 ST900 / W27 ST900	03760225714027	Outer Diameter 2.7 mm Single use: yes	No longer on the market

NEOVIEW Plating System

Regulatory status

Across registries

Recalls

Timeline

Coverage

Specification

Overview

Devices cleared under K160995

Similar devices

Other devices from In2Bones SAS

Neofit®

Neofuse

Ibs™

Kirschner wire

Regulatory status

Across registries

Recalls

Timeline

Coverage

Specification

Related clearances

Cites

Cited by

Overview

Devices cleared under K160995

Similar devices

Other devices from In2Bones SAS

Neofit®

Neofuse

Ibs™

Kirschner wire