Neofuse
Locking Screw DIAM3.5 & CAP Titanium Sterile LG48MM
31manufacturers in China registered for this device type
52catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | IN2BONES USA, LLC, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K173121 |
| Record published | 2019-07-17 |
| Record revised | 2026-04-21 (version 12) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: KEEP DRY |
| Sizes | Length 12 to 95 mm; outer diameter 3.5 to 28 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V35 ST548 | Length 48 mm | In distribution |
| V45 ST550 | Length 50 mm | In distribution |
| V35 ST550 | Length 50 mm | In distribution |
| V45 ST175 | Length 75 mm | In distribution |
| V45 ST180 | Length 80 mm | In distribution |
| V45 ST520 | Length 20 mm | In distribution |
| V35 ST528 | Length 28 mm | In distribution |
| V45 ST150 | Length 50 mm | In distribution |
| V45 ST528 | Length 28 mm | In distribution |
| V45 ST540 | Length 40 mm | In distribution |
| V45 ST518 | Length 18 mm | In distribution |
| V45 ST536 | Length 36 mm | In distribution |
| V35 ST514 | Length 12 mm | In distribution |
| V35 ST526 | Length 26 mm | In distribution |
| V45 ST146 | Length 46 mm | In distribution |
| V45 ST165 | Length 65 mm | In distribution |
| V45 ST530 | Length 30 mm | In distribution |
| V35 ST546 | Length 46 mm | In distribution |
| V35 ST536 | Length 36 mm | In distribution |
| V45 ST195 | Length 95 mm | In distribution |
| V35 ST520 | Length 18 mm | In distribution |
| V45 ST544 | Length 44 mm | In distribution |
| V45 ST140 | Length 40 mm | In distribution |
| V35 ST538 | Length 38 mm | In distribution |
| V45 ST526 | Length 26 mm | In distribution |
| V35 ST542 | Length 42 mm | In distribution |
| V45 ST144 | Length 44 mm | In distribution |
| V45 ST170 | Length 70 mm | In distribution |
| V35 ST524 | Length 22 mm | In distribution |
| V45 ST148 | Length 48 mm | In distribution |
| V35 ST512 | Length 12 mm | In distribution |
| V35 ST534 | Length 34 mm | In distribution |
| V45 ST185 | Length 85 mm | In distribution |
| V45 ST160 | Length 60 mm | In distribution |
| V35 ST518 | Length 18 mm | In distribution |
| V45 ST155 | Length 55 mm | In distribution |
| V45 ST548 | Length 48 mm | In distribution |
| V45 ST538 | Length 38 mm | In distribution |
| V45 ST524 | Length 24 mm | In distribution |
| V45 ST532 | Length 32 mm | In distribution |
| V45 ST142 | Length 42 mm | In distribution |
| V35 ST522 | Length 22 mm | In distribution |
| V35 ST544 | Length 44 mm | In distribution |
| V45 ST534 | Length 34 mm | In distribution |
| V45 ST546 | Length 46 mm | In distribution |
| V45 ST190 | Length 90 mm | In distribution |
| V45 ST542 | Length 42 mm | In distribution |
| V35 ST516 | Length 16 mm | In distribution |
| V35 ST540 | Length 40 mm | In distribution |
| V35 ST532 | Length 32 mm | In distribution |
| V35 ST530 | Length 30 mm | In distribution |
| V45 ST522 | Length 22 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261154 | 2026-05-30 |
| K231236 | 2023-07-27 |
| K180377 | 2018-06-20 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-07-16 | Class II | Process control | CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates. | 48 units | 2019-02-22 |
| 2018-07-16 | Class II | Process control | CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates. | 47 units | 2019-02-22 |
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.