Artisan™ Space Maintenance System
Tent Screw 7000006 1.4 MM X 12 MM (4/PK)
3manufacturers in China registered for this device type
20catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| 510(k) | K110259 |
| Record published | 2015-09-15 |
| Record revised | 2024-09-11 (version 5) |
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 3 to 20 mm; outer diameter 1.2 to 1.4 mm |
| Distribution end date | 2018-10-08 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 7451218 | Length 18.0 mm | 4 | In distribution |
| 7000053 | Outer Diameter 1.2 mm | 6 | In distribution |
| 7561214 | Length 14.0 mm | 4 | In distribution |
| 7000051 | Outer Diameter 1.2 mm | 6 | In distribution |
| 7000006 | Length 12.0 mm | 4 | In distribution |
| 7000017 | Length 14.0 mm | 4 | In distribution |
| 7000015 | Length 10.0 mm | 4 | In distribution |
| 7451220 | Length 20.0 mm | 4 | In distribution |
| 7000016 | Length 12.0 mm | 4 | In distribution |
| 7000014 | Outer Diameter 1.2 mm | 4 | In distribution |
| 7341220 | Outer Diameter 1.2 mm | 4 | In distribution |
| 7000040 | In distribution | ||
| 7000056 | Outer Diameter 1.4 mm | 6 | Withdrawn |
| 7341218 | Length 18.0 mm | 4 | Withdrawn |
| 7561216 | Length 16.0 mm | 4 | Withdrawn |
| 7451420 | Length 20.0 mm | 4 | Withdrawn |
| 7000052 | Length 8.0 mm | 6 | Withdrawn |
| 7000054 | Length 12.0 mm | 6 | Withdrawn |
| 7000058 | Outer Diameter 1.4 mm | 6 | Withdrawn |
| 7000007 | Outer Diameter 1.4 mm | 4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plate, Bone | Stryker Leibinger Gmbh & Co. KG | 1,338 |
| Level ONE CMF | KLS-Martin L.P. | 1,160 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 843 |
| OsteoMed | Osteomed | 675 |
| Bioplate® | Bioplate, Inc. | 669 |
| Plate, Bone | Synthes Gmbh | 568 |
| Leforte System Bone Plate | Jeil Medical Corporation | 466 |
| CMF Visionare | Visionare LLC | 421 |
| Level ONE CMF, Sterile | KLS-Martin L.P. | 416 |
| Faico CMF System | Faico Medical, LLC | 361 |
| TraumaOne System | Biomet Microfixation | 357 |
| MatrixMANDIBLE | Synthes Gmbh | 277 |
Showing 12 of 152. All products under Plate, Bone
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.