ProPlan CMF
Patient Specific Instrument and Planning Kit, Mandible Reconstruction, no model
3manufacturers in China registered for this device type
16catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Materialise NV, Belgium |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| 510(k) | K103136 |
| Record published | 2016-09-13 |
| Record revised | 2019-11-27 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2017-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD900.003 | In distribution | |
| SD900.104 | In distribution | |
| SD900.056 | In distribution | |
| SD900.001 | In distribution | |
| SD900.054 | In distribution | |
| SD900.111 | In distribution | |
| SD900.004 | In distribution | |
| SD900.102 | In distribution | |
| SD900.051 | In distribution | |
| SD900.006 | In distribution | |
| SD900.101 | In distribution | |
| SD900.107 | In distribution | |
| SD900.105 | Withdrawn | |
| SD900.009 | Withdrawn | |
| SD900.008 | Withdrawn | |
| SD900.106 | Withdrawn |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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173039 | 2018-07-10 |
| K170272 | 2017-08-08 |
| K103136 | 2011-03-18 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Materialise N.V. | 510(k) number | 2023-06-19 | Class II | Process change control | Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request | 1 unit |
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.