SMV Interlocking Schanz Screw
250mm, 5.0mm SMV Interlocking Centrally Threaded Schanz Screw, Self-Tapping
31manufacturers in China registered for this device type
26catalogue numbers in this listing
4510(k) clearances naming this product 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 | OsteoCentric Technologies,Inc, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K160603 |
| Record published | 2016-11-04 |
| Record revised | 2025-07-02 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 80 to 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 350-4105 | Length 105 mm | In distribution |
| 350-4125 | Length 125 mm | In distribution |
| 350-6250 | Length 200 mm | In distribution |
| 350-4165 | Length 165 mm | In distribution |
| 350-4120 | Length 120 mm | In distribution |
| 350-4085 | Length 85 mm | In distribution |
| 350-4135 | Length 135 mm | In distribution |
| 350-4180 | Length 180 mm | In distribution |
| 350-4130 | Length 130 mm | In distribution |
| 350-4145 | Length 145 mm | In distribution |
| 350-4170 | Length 170 mm | In distribution |
| 350-4190 | Length 190 mm | In distribution |
| 350-4150 | Length 150 mm | In distribution |
| 350-4110 | Length 110 mm | In distribution |
| 350-4195 | Length 195 mm | In distribution |
| 350-4140 | Length 140 mm | In distribution |
| 350-4160 | Length 160 mm | In distribution |
| 350-4175 | Length 175 mm | In distribution |
| 350-4095 | Length 95 mm | In distribution |
| 350-4100 | Length 100 mm | In distribution |
| 350-4155 | Length 155 mm | In distribution |
| 350-4115 | Length 115 mm | In distribution |
| 350-4185 | Length 185 mm | In distribution |
| 350-4080 | Length 80 mm | In distribution |
| 350-4090 | Length 90 mm | In distribution |
| 350-4200 | Length 200 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 |
|---|---|
| K242691 | 2024-10-09 |
| K230595 | 2023-06-29 |
| K211290 | 2021-08-03 |
| K210754 | 2021-04-14 |
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.