Salvation
Midfoot Nail
31manufacturers in China registered for this device type
118catalogue numbers in this listing
2510(k) clearances naming this product code
8recalls 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 | Wright Medical Technology, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180024 |
| Record published | 2015-10-01 |
| Record revised | 2025-02-06 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Length 34 to 180 mm; outer diameter 4 to 8 mm; height 5 to 12 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SB050155 | Length 155 mm | In distribution |
| SB017080 | Length 80 mm | In distribution |
| SB170110 | Length 110 mm | In distribution |
| SB170120 | Length 120 mm | In distribution |
| SB006595 | Length 95 mm | In distribution |
| SP224034 | Length 34 mm | In distribution |
| SB017055 | Outer Diameter 7 mm | In distribution |
| SMN08095 | Cannulated | In distribution |
| SB070170 | Length 170 mm | In distribution |
| SB065140 | Outer Diameter 6.5 mm | In distribution |
| SB070180 | Outer Diameter 7 mm | In distribution |
| SB070125 | Length 125 mm | In distribution |
| SB170160 | Outer Diameter 7 mm | In distribution |
| SB170115 | Length 115 mm | In distribution |
| SB050130 | Length 130 mm | In distribution |
| SB170155 | Length 155 mm | In distribution |
| SB017075 | Length 75 mm | In distribution |
| SB005090 | Outer Diameter 5 mm | In distribution |
| SB070150 | Outer Diameter 7 mm | In distribution |
| SB005075 | Length 75 mm | In distribution |
| SB065120 | Outer Diameter 6.5 mm | In distribution |
| SMN08120 | Length 120 mm | In distribution |
| SB007050 | Outer Diameter 7 mm | In distribution |
| SB170125 | Outer Diameter 7 mm | In distribution |
| SB065145 | Outer Diameter 6.5 mm | In distribution |
| SB050115 | Outer Diameter 5 mm | In distribution |
| SB070120 | Length 120 mm | In distribution |
| SMN08105 | Cannulated | In distribution |
| SB007095 | Length 95 mm | In distribution |
| SMN08140 | Outer Diameter 8 mm | In distribution |
| SB050140 | Length 140 mm | In distribution |
| SB170140 | Length 140 mm | In distribution |
| SB070160 | Length 160 mm | In distribution |
| SB065160 | Outer Diameter 6.5 mm | In distribution |
| SMN08115 | Cannulated | In distribution |
| SMN08090 | Length 90 mm | In distribution |
| SMN08155 | Outer Diameter 8 mm | In distribution |
| SB170145 | Outer Diameter 7 mm | In distribution |
| SMN08100 | Length 100 mm | In distribution |
| SB007070 | Length 70 mm | In distribution |
| SB065155 | Length 155 mm | In distribution |
| SMN08080 | Cannulated | In distribution |
| SB170175 | Length 175 mm | In distribution |
| SB017050 | Length 50 mm | In distribution |
| SB006585 | Length 85 mm | In distribution |
| SB017095 | Outer Diameter 7 mm | In distribution |
| SB007060 | Outer Diameter 7 mm | In distribution |
| SB065170 | Outer Diameter 6.5 mm | In distribution |
| SB065110 | Outer Diameter 6.5 mm | In distribution |
| SB050120 | Length 120 mm | In distribution |
| SB070130 | Length 130 mm | In distribution |
| SMN08065 | Length 65 mm | In distribution |
| SMN08110 | Length 110 mm | In distribution |
| SMN08160 | Cannulated | In distribution |
| SB050160 | Outer Diameter 5 mm | In distribution |
| SMN08145 | Length 145 mm | In distribution |
| SB007055 | Length 55 mm | In distribution |
| SB170130 | Outer Diameter 7 mm | In distribution |
| SMN08075 | Cannulated | In distribution |
| SB170135 | Length 135 mm | In distribution |
| SMN08130 | Cannulated | In distribution |
| SB017090 | Outer Diameter 7 mm | In distribution |
| SB065150 | Length 150 mm | In distribution |
| SB065180 | Outer Diameter 6.5 mm | In distribution |
| SB007075 | Thread length: 23.5 millimeter | In distribution |
| SB006580 | Length 80 mm | In distribution |
| SB017085 | Outer Diameter 7 mm | In distribution |
| SB065135 | Outer Diameter 6.5 mm | In distribution |
| SB005080 | Length 80 mm | In distribution |
| SB170105 | Length 105 mm | In distribution |
| SMN08060 | Cannulated | In distribution |
| SB050145 | Length 145 mm | In distribution |
| SB070100 | Length 100 mm | In distribution |
| SB050135 | Length 135 mm | In distribution |
| SB070165 | Length 165 mm | In distribution |
| SMN08085 | Outer Diameter 8 mm | In distribution |
| SB005065 | Thread length: 23 millimeter | In distribution |
| SB007090 | Outer Diameter 7 mm | In distribution |
| SB050125 | Length 125 mm | In distribution |
| SB070155 | Length 155 mm | In distribution |
| SB050150 | Length 150 mm | In distribution |
| SB065100 | Outer Diameter 6.5 mm | In distribution |
| SB050100 | Outer Diameter 5 mm | In distribution |
| SB170100 | Outer Diameter 7 mm | In distribution |
| SB170165 | Length 165 mm | In distribution |
| SB007085 | Outer Diameter 7 mm | In distribution |
| SB170170 | Outer Diameter 7 mm | In distribution |
| SB070110 | Length 110 mm | In distribution |
| SB005085 | Outer Diameter 5 mm | In distribution |
| SB017060 | Outer Diameter 7 mm | In distribution |
| SB065115 | Length 115 mm | In distribution |
| SB006590 | Length 90 mm | In distribution |
| SB005060 | Thread length: 23 millimeter | In distribution |
| SB065165 | Length 165 mm | In distribution |
| SB070105 | Length 105 mm | In distribution |
| SMN08070 | Cannulated | In distribution |
| SB050105 | Outer Diameter 5 mm | In distribution |
| SB070145 | Length 145 mm | In distribution |
| SB070115 | Length 115 mm | In distribution |
| SB065105 | Length 105 mm | In distribution |
| SB070140 | Outer Diameter 7 mm | In distribution |
| SMN08150 | Length 150 mm | In distribution |
| SB070175 | Outer Diameter 7 mm | In distribution |
| SB170150 | Length 150 mm | In distribution |
| SB017070 | Outer Diameter 7 mm | In distribution |
| SMN08135 | Cannulated | In distribution |
| SB017065 | Outer Diameter 7 mm | In distribution |
| SB070135 | Outer Diameter 7 mm | In distribution |
| SB007080 | Outer Diameter 7 mm | In distribution |
| SB005070 | Length 70 mm | In distribution |
| SB065175 | Length 175 mm | In distribution |
| SB065125 | Length 125 mm | In distribution |
| SB050110 | Length 110 mm | In distribution |
| SB005095 | Length 95 mm | In distribution |
| SMN08125 | Cannulated | In distribution |
| SB170180 | Length 180 mm | In distribution |
| SB065130 | Length 130 mm | In distribution |
| SB007065 | Length 65 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 |
|---|---|
| K221645 | 2023-02-17 |
| K203228 | 2021-05-11 |
Recalls
6 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 |
|---|---|---|---|---|---|
| 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 40 units | 2020-11-03 |
| 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 77 units | 2020-11-03 |
| 2015-04-16 | Class II | Process control | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 121 units | 2018-10-18 |
| 2015-04-16 | Class II | Process control | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 126 units | 2018-10-18 |
| 2015-04-16 | Class II | Process control | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 126 units | 2018-10-18 |
| 2015-04-16 | Class II | Process control | The term DORSAL was laser etched on the incorrect side on some of the angled handles. | 124 units | 2018-10-18 |
| 2011-04-20 | Not classified | Process control | Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery. | 65 | 2012-12-27 |
| 2011-04-20 | Not classified | Process control | Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery. | 121 | 2012-12-27 |
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.