OsteoMed
MFx 125 Degree Angulated Locking Contoured Reconstruction Plate, Left 5 x 16 x 5 Hole
3manufacturers in China registered for this device type
675catalogue numbers in this listing
4510(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 | Osteomed, United States |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-07-22 |
| Record revised | 2025-06-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store at controlled room temperature out of direct sunlight |
| Sizes | Length 2 to 266 mm; height 2.8 to 22 mm; outer diameter 18 to 25 mm; angle 125 ° |
| Distribution end date | 2019-12-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 220-0640-14 | In distribution | |
| 212-1682 | Thickness = 0.3mm | In distribution |
| 213-0154 | In distribution | |
| 225-2722 | Length 22 mm | In distribution |
| 231-2812T | Length 146 mm | In distribution |
| 220-0644-48 | In distribution | |
| 220-0644-93 | In distribution | |
| 225-2005 | Length 5 mm | In distribution |
| 213-0155 | In distribution | |
| 220-0644-83 | In distribution | |
| 220-0802-04 | In distribution | |
| 225-2008 | Length 8 mm | In distribution |
| 213-1624 | Length 203 mm | In distribution |
| 213-1620 | Length 93 mm | In distribution |
| 231-1024 | Length 117 mm | In distribution |
| 220-0644-41 | In distribution | |
| 220-0643-14 | In distribution | |
| 220-0643-89 | In distribution | |
| 231-2821 | Thickness = 2.8mm | In distribution |
| 214-0113-SP-02 | Length 35 mm | In distribution |
| 231-2011 | Thickness = 2.0mm | In distribution |
| 220-0801-03 | In distribution | |
| 220-0802-01 | In distribution | |
| 231-1022 | Length 35 mm | In distribution |
| 231-2802 | Thickness = 2.8mm | In distribution |
| 220-0644-40 | In distribution | |
| 220-0884 | In distribution | |
| 220-0625-20 | In distribution | |
| 232-2010 | Length 10 mm | In distribution |
| 214-2031 | Length 33 mm | In distribution |
| 220-0811 | In distribution | |
| 206-0214-SP-02 | Length 14 mm | In distribution |
| 231-1051T | Length 13 mm | In distribution |
| 220-0641-66 | In distribution | |
| 213-0058-SP-02 | Advancement = 12mm | In distribution |
| 213-0149 | In distribution | |
| 220-0644-85 | In distribution | |
| 231-1021 | Length 21 mm | In distribution |
| 220-0641-61 | In distribution | |
| 231-1022T | Length 35 mm | In distribution |
| 231-1035 | Length 28 mm | In distribution |
| 212-0064 | Outer Diameter 18 mm | In distribution |
| 202-2020 | Length 20 mm | In distribution |
| 231-1052T | Length 25 mm | In distribution |
| 206-0214 | Length 14 mm | In distribution |
| 214-2410 | Length 119 mm | In distribution |
| 213-0085 | Advancement = 7mm | In distribution |
| 213-1697 | Thickness = 0.5mm | In distribution |
| 220-0810 | In distribution | |
| 213-0156 | In distribution | |
| 220-0643-02 | In distribution | |
| 212-1664 | Thickness = 0.5mm | In distribution |
| 220-0640-18 | In distribution | |
| 210-0040 | Advancement = 4mm | In distribution |
| 233-2005 | Length 5 mm | In distribution |
| 213-1675 | Thickness = 0.4mm | In distribution |
| 225-2306 | Length 6 mm | In distribution |
| 220-0643-16 | In distribution | |
| 208-1908 | Length 8 mm | In distribution |
| 212-0052 | Length 19 mm | In distribution |
| 220-0813 | In distribution | |
| 214-2403 | Length 37 mm | In distribution |
| 214-2043 | Length 51 mm | In distribution |
| 213-0048-SP-02 | Advancement = 2mm | In distribution |
| 213-0052-SP-02 | Advancement = 6mm | In distribution |
| 210-0006T | Length 15 mm | In distribution |
| 220-0643-39 | In distribution | |
| 214-2408 | Thickness = 1.5mm | In distribution |
| 213-0055-SP-02 | Advancement = 8mm | In distribution |
| 206-0220 | Length 20 mm | In distribution |
| 223-2408 | Length 8 mm | In distribution |
| 202-2020-SP-05 | Length 20 mm | In distribution |
| 231-1035T | Length 28 mm | In distribution |
| 208-1904 | Length 4 mm | In distribution |
| 303-1210 | Length 10 mm | In distribution |
| 208-1906 | Length 6 mm | In distribution |
| 220-0643-43 | In distribution | |
| 206-0204 | Length 4 mm | In distribution |
| 231-1041 | Thickness = 1.0mm | In distribution |
| 214-2039 | Length 20 mm | In distribution |
| 231-2021 | Thickness = 2.0mm | In distribution |
| 220-0452 | In distribution | |
| 212-1694 | Thickness = 0.5mm | In distribution |
| 206-0206 | Length 6 mm | In distribution |
| 213-0053 | Advancement = 6mm | In distribution |
| 210-0418-SP-05 | Advancement = 6mm | In distribution |
| 206-0212 | Length 12 mm | In distribution |
| 214-2420 | Thickness = 2.5mm | In distribution |
| 220-0641-43 | In distribution | |
| 220-0814 | In distribution | |
| 220-0851 | In distribution | |
| 214-2036 | Length 47 mm | In distribution |
| 220-0644-100 | In distribution | |
| 220-0644-81 | In distribution | |
| 210-0421-SP-02 | Advancement = 12mm | In distribution |
| 204-1210-SP-10 | Length 10 mm | In distribution |
| 220-0723 | In distribution | |
| 225-2414 | Length 14 mm | In distribution |
| 212-0052-SP-02 | Length 19 mm | In distribution |
| 206-0210 | Length 10 mm | In distribution |
| 220-0641-69 | In distribution | |
| 220-0643-00 | In distribution | |
| 214-0403 | Length 117 mm | In distribution |
| 205-1607 | Length 7 mm | In distribution |
| 213-0153 | In distribution | |
| 212-0048-SP-02 | Length 16 mm | In distribution |
| 213-0203 | Span Length = 3mm | In distribution |
| 220-0618-06 | In distribution | |
| 214-2007 | Length 47 mm | In distribution |
| 214-2011 | Length 31 mm | In distribution |
| 231-2001 | Thickness = 2.0mm | In distribution |
| 213-0065 | Length 15 mm | In distribution |
| 214-0086 | Length 20 mm | In distribution |
| 231-2825 | Height 2.8 mm | In distribution |
| 220-0643-19 | In distribution | |
| 231-1054 | Length 25 mm | In distribution |
| 231-1012 | Length 38 mm | In distribution |
| 232-2014 | Length 14 mm | In distribution |
| 210-0044 | Advancement = 8mm | In distribution |
| 213-0206 | Span Length = 5mm | In distribution |
| 213-0185 | In distribution | |
| 214-2044 | Length 27 mm | In distribution |
| 210-0065 | Advancement = 11mm | In distribution |
| 213-0056-SP-02 | Advancement = 10mm | In distribution |
| 202-2022-SP-05 | Length 22 mm | In distribution |
| 213-1692 | Thickness = 0.25mm | In distribution |
| 220-0871 | In distribution | |
| 213-1691 | Thickness = 0.2mm | In distribution |
| 231-1032T | Length 37 mm | In distribution |
| 231-1002T | Length 34 mm | In distribution |
| 225-2012 | Length 12 mm | In distribution |
| 231-1042 | Thickness = 1.0mm | In distribution |
| 220-0644-99 | In distribution | |
| 220-0644-30 | In distribution | |
| 214-2051-SP-02 | Length 25 mm | In distribution |
| 220-0644-96 | In distribution | |
| 212-0046-SP-02 | Length 13 mm | In distribution |
| 220-0618-00 | In distribution | |
| 220-0641-72 | In distribution | |
| 214-2030 | Length 29 mm | In distribution |
| 231-2012 | Thickness = 2.0mm | In distribution |
| 220-0640-23 | In distribution | |
| 212-1684 | Thickness = 0.5mm | In distribution |
| 210-0418 | Advancement = 6mm | In distribution |
| 231-2802T | Length 178 mm | In distribution |
| 220-0644-47 | In distribution | |
| 204-1212-SP | Length 12 mm | In distribution |
| 214-0112-SP-02 | Length 31 mm | In distribution |
| 214-2046 | Length 25 mm | In distribution |
| 214-2010 | Length 27 mm | In distribution |
| 220-0641-70 | In distribution | |
| 210-0048 | Advancement = 12mm | In distribution |
| 213-0057-SP-02 | Advancement = 10mm | In distribution |
| 220-0643-13 | In distribution | |
| 225-2305 | Length 5 mm | In distribution |
| 231-2814 | Thickness = 2.8mm | In distribution |
| 214-2038 | Length 34 mm | In distribution |
| 217-1904 | Length 4 mm | In distribution |
| 208-1912 | Length 12 mm | In distribution |
| 220-0801-05 | In distribution | |
| 213-0048 | Advancement = 2mm | In distribution |
| 214-2005 | Length 80 mm | In distribution |
| 231-1012T | Length 38 mm | In distribution |
| 208-1914 | Length 14 mm | In distribution |
| 220-0632 | In distribution | |
| 220-0643-06 | In distribution | |
| 241-2802 | Thickness = 2.8mm | In distribution |
| 231-2811 | Thickness = 2.8mm | In distribution |
| 220-2052 | In distribution | |
| 213-1612 | Length 93 mm | In distribution |
| 212-1693 | Thickness = 0.4mm | In distribution |
| 213-1662 | Thickness = 0.25mm | In distribution |
| 213-1685 | Thickness = 0.4mm | In distribution |
| 231-1024T | Length 117 mm | In distribution |
| 220-0641-16 | In distribution | |
| 220-0619-12 | In distribution | |
| 214-2409 | Thickness = 1.5mm | In distribution |
| 213-0050-SP-02 | Advancement = 4mm | In distribution |
| 220-0641-12 | In distribution | |
| 220-0644-90 | In distribution | |
| 220-0802-03 | In distribution | |
| 213-0062 | Length 15 mm | In distribution |
| 250-0054 | In distribution | |
| 220-0641-73 | In distribution | |
| 231-2827 | Height 2.8 mm | In distribution |
| 214-2006 | Length 21 mm | In distribution |
| 232-2410 | Length 10 mm | In distribution |
| 213-0063 | Length 15 mm | In distribution |
| 214-0085 | Length 15 mm | In distribution |
| 210-0040-SP-02 | Advancement = 4mm | In distribution |
| 210-0412 | Advancement = 12mm | In distribution |
| 220-0619-04 | In distribution | |
| 225-2310 | Length 10 mm | In distribution |
| 225-2308 | Length 8 mm | In distribution |
| 231-1011 | Length 34 mm | In distribution |
| 213-0051-SP-02 | Advancement = 4mm | In distribution |
| 223-2005 | Length 5 mm | In distribution |
| 210-0034-SP | Length 87 mm | In distribution |
| 220-0643-17 | In distribution | |
| 213-0082 | Advancement = 5mm | In distribution |
| 220-0644-34 | In distribution | |
| 220-0884-01 | In distribution | |
| 220-0641-71 | In distribution | |
| 213-0204 | Span Length = 4mm | In distribution |
| 214-2008 | Length 37 mm | In distribution |
| 213-0181 | In distribution | |
| 220-0644-95 | In distribution | |
| 213-1613-SP-01 | Length 93 mm | In distribution |
| 213-1665 | Thickness = 0.4mm | In distribution |
| 225-2410 | Length 10 mm | In distribution |
| 213-0081 | Advancement = 3mm | In distribution |
| 210-0042 | Advancement = 6mm | In distribution |
| 220-0644-43 | In distribution | |
| 220-0640-71 | In distribution | |
| 214-2028 | Thickness = 2.0mm | In distribution |
| 220-0820 | In distribution | |
| 220-0641-17 | In distribution | |
| 202-0214 | Length 14 mm | In distribution |
| 213-0080 | Advancement = 3mm | In distribution |
| 231-1023 | Length 90 mm | In distribution |
| 202-0300 | Length 2 mm | In distribution |
| 210-0406 | Advancement = 6mm | In distribution |
| 220-0607 | In distribution | |
| 220-0640-00 | In distribution | |
| 214-2416 | Thickness = 2.5mm | In distribution |
| 220-0618-08 | In distribution | |
| 225-2016 | Length 16 mm | In distribution |
| 202-0218 | Length 18 mm | In distribution |
| 213-0212 | Span Length = 8mm | In distribution |
| 210-0042-SP | Advancement = 6mm | In distribution |
| 220-0852 | In distribution | |
| 210-0408 | Advancement = 8mm | In distribution |
| 220-0643-20 | In distribution | |
| 213-1614 | Length 203 mm | In distribution |
| 206-0216-SP-02 | Length 16 mm | In distribution |
| 220-0644-92 | In distribution | |
| 220-0640-67 | In distribution | |
| 231-2021T | Length 204 mm | In distribution |
| 233-2408 | Length 8 mm | In distribution |
| 210-0044-SP-02 | Advancement = 8mm | In distribution |
| 213-0157 | In distribution | |
| 220-0618-04 | In distribution | |
| 213-0202 | Span Length = 3mm | In distribution |
| 232-2018 | Length 18 mm | In distribution |
| 210-0040-SP | Advancement = 4mm | In distribution |
| 214-2017 | Thickness = 1.0mm | In distribution |
| 213-0210 | Span Length = 7mm | In distribution |
| 210-0034 | Length 87 mm | In distribution |
| 220-0619-06 | In distribution | |
| 214-2414 | Thickness = 2.5mm | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Level ONE Neuro | KLS-Martin L.P. | 253 |
Showing 12 of 152. All products under Plate, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140978 | 2014-12-18 |
| K021618 | 2002-08-08 |
| K963394 | 1996-11-14 |
| K924138 | 1993-02-17 |
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.