CyclaPlex Drill Guide
The CyclaPlex Drill Guide is a “H arm” device intended to guide drill bits at the right points and required drilling angles in the 1st and 2nd metatarsal bones.
9manufacturers in China registered for this device type
1catalogue number
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 | Alphamet Ltd |
|---|---|
| FDA product code | HTN |
| Device type | Washer, Bolt Nut |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K183094 |
| Record published | 2020-02-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V7 | 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 |
| AC Device | Lockdown Medical Limited | 31 |
| Evos | Smith & Nephew, Inc. | 28 |
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.