Neofit®
Neofit Screw - NON-Locking Diam 2.7MM - LG 14MM
22manufacturers in China registered for this device type
32catalogue 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 | 2024-12-13 |
| Record revised | 2025-12-15 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-08-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V27 ST114 | Withdrawn | |
| V27 ST014 | Withdrawn | |
| V27 ST012 | Withdrawn | |
| V30 ST110 | Withdrawn | |
| V27 ST016 | Withdrawn | |
| V30 ST016 | Withdrawn | |
| V27 ST118 | Withdrawn | |
| P10 ST140 | Withdrawn | |
| P10 ST245 | Withdrawn | |
| V30 ST112 | Withdrawn | |
| P10 ST235 | Withdrawn | |
| P10 ST135 | Withdrawn | |
| V30 ST118 | Withdrawn | |
| V30 ST116 | Withdrawn | |
| V30 ST012 | Withdrawn | |
| V30 ST114 | Withdrawn | |
| P10 ST240 | Withdrawn | |
| V27 ST018 | Withdrawn | |
| V27 ST116 | Withdrawn | |
| V30 ST014 | Withdrawn | |
| V30 ST018 | Withdrawn | |
| V30 ST120 | Withdrawn | |
| V27 ST020 | Withdrawn | |
| V27 ST110 | Withdrawn | |
| P10 ST145 | Withdrawn | |
| P10 ST250 | Withdrawn | |
| V30 ST010 | Withdrawn | |
| V27 ST010 | Withdrawn | |
| V27 ST112 | Withdrawn | |
| P10 ST150 | Withdrawn | |
| V27 ST120 | Withdrawn | |
| V30 ST020 | 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.