AC Device
36mm Cortical Screw (3.5mm Dia) & 1mm Washer (SS)
9manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (3), Zhejiang (1). 4 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Lockdown Medical Limited, United Kingdom |
|---|---|
| FDA product code | HTN |
| Device type | Washer, Bolt Nut |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K091207 |
| Record published | 2015-10-30 |
| Record revised | 2021-11-23 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 1.4 to 20 cm; outer diameter 0.9 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LD180 | Length 18 cm | In distribution |
| LD080 | Length 8 cm | In distribution |
| LDSS36 | Length 3.6 cm | In distribution |
| LD120 | Length 12 cm | In distribution |
| LDSS34 | Length 3.4 cm | In distribution |
| LDSS16 | Length 1.6 cm | In distribution |
| LD190 | Length 19 cm | In distribution |
| LDSS32 | Length 3.2 cm | In distribution |
| LDCW09 | Outer Diameter 0.9 cm | In distribution |
| LD060 | Length 6 cm | In distribution |
| LDSS24 | Length 2.4 cm | In distribution |
| LD160 | Length 16 cm | In distribution |
| LDSS18 | Length 1.6 cm | In distribution |
| LD070 | Length 7 cm | In distribution |
| LDSS26 | Length 2.6 cm | In distribution |
| LDSS38 | Length 3.8 cm | In distribution |
| LDSS22 | Length 2.2 cm | In distribution |
| LDSS14 | Length 1.4 cm | In distribution |
| LDSS20 | Length 2 cm | In distribution |
| LDSS30 | Length 3 cm | In distribution |
| LD170 | Length 17 cm | In distribution |
| LD140 | Length 14 cm | In distribution |
| LD090 | Length 9 cm | In distribution |
| LDSS40 | Length 4 cm | In distribution |
| LD150 | In distribution | |
| LD110 | Length 11 cm | In distribution |
| LD130 | Length 13 cm | In distribution |
| LD050 | Length 5 cm | In distribution |
| LD200 | Length 20 cm | In distribution |
| LDSS28 | Length 2.8 cm | In distribution |
| LD100 | Length 10 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Washer, Bolt Nut | Zimmer, Inc. | 308 |
| MaxTorque™ | Tornier Inc. | 171 |
| Arthrex® | Arthrex, Inc. | 154 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 92 |
| Washer, Bolt Nut | Synthes Gmbh | 88 |
| A.l.p.s.® | Biomet Orthopedics | 67 |
| Variax | Stryker GmbH | 59 |
| Conmed | ConMed Corporation | 38 |
| Neoortho | Neoortho Produtos Ortopédicos S/A | 32 |
| Aptus | Medartis Inc. | 31 |
| Evos | Smith & Nephew, Inc. | 28 |
| Axis | Extremity Medical, LLC | 26 |
Showing 12 of 304. All products under Washer, Bolt Nut
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.