Neoview®
NEO screw – non locking – Dia 2.7mm – Lg 10mm
22manufacturers in China registered for this device type
27catalogue numbers in this listing
2510(k) clearances naming this product code
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | In2Bones SAS, France |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K160995 |
| Record published | 2016-07-01 |
| Record revised | 2025-12-15 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 10 to 54.83 mm; outer diameter 2.7 mm; width 22.9 to 25.9 mm |
| Distribution end date | 2024-12-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P30 SP110 | Width 22.90 mm | In distribution |
| P30 SP210 | Width 22.90 mm | In distribution |
| P30 SP120 | Length 54.83 mm | In distribution |
| P30 SP220 | Length 54.83 mm | In distribution |
| W27 ST010 | Length 10 mm | Withdrawn |
| W27 ST022 | Length 22 mm | Withdrawn |
| W27 ST126 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST026 | Length 26 mm | Withdrawn |
| W27 ST110 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST012 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST124 | Length 24 mm | Withdrawn |
| W27 ST030 | Length 30 mm | Withdrawn |
| W27 ST028 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST024 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST112 | Length 12 mm | Withdrawn |
| W27 ST016 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST020 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST128 | Length 28 mm | Withdrawn |
| W27 ST116 | Length 16 mm | Withdrawn |
| W27 ST118 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST120 | Length 20 mm | Withdrawn |
| W27 ST900 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST018 | Length 18 mm | Withdrawn |
| W27 ST114 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST122 | Outer Diameter 2.7 mm | Withdrawn |
| W27 ST014 | Length 14 mm | Withdrawn |
| W27 ST130 | Outer Diameter 2.7 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173121 | 2017-11-28 |
| K160995 | 2016-06-10 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| In2Bones SAS | 510(k) number | 2017-07-13 | Class II | Device Design | The firm received several customer complaints reporting some perioperative breakages of NE0411 Non-Locking screws when inserting the screw into the radius diaphysis | 287 screws | 2018-08-27 |
| In2Bones SAS | 510(k) number | 2016-12-19 | Class II | Component design/selection | Dimensional non-conformity of the thread on the screw head. | 19 units | 2017-02-01 |
| In2Bones SAS | 510(k) number | 2016-12-19 | Class II | Component design/selection | Dimensional non-conformity of the thread on the screw head. | 40 units | 2017-02-01 |
| In2Bones SAS | 510(k) number | 2016-12-19 | Class II | Component design/selection | Dimensional non-conformity of the thread on the screw head. | 26 units | 2017-02-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.