Plate, Bone
LOW Prof Neuro Contour TI Mesh Malleable Mastoid/LRG-Sterile
3manufacturers in China registered for this device type
568catalogue numbers in this listing
4510(k) clearances naming this product code
1recall
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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K022012 |
| Record published | 2015-09-14 |
| Record revised | 2026-04-06 (version 9) |
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 |
| Distribution end date | 2024-07-10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 421.503 | In distribution | ||
| 421.024 | In distribution | ||
| 449.020 | In distribution | ||
| 447.310 | In distribution | ||
| 449.100 | In distribution | ||
| 400.786E | In distribution | ||
| 447.148 | In distribution | ||
| 401.935 | 5 | In distribution | |
| 288.010 | In distribution | ||
| 447.030 | In distribution | ||
| 447.572 | In distribution | ||
| 447.084 | In distribution | ||
| 446.44 | In distribution | ||
| 401.524.96 | In distribution | ||
| 447.556 | In distribution | ||
| 421.071 | In distribution | ||
| 421.009 | In distribution | ||
| 421.502 | In distribution | ||
| 401.507.96 | In distribution | ||
| 487.989 | In distribution | ||
| 400.855 | 5 | In distribution | |
| 421.045 | In distribution | ||
| 447.305 | In distribution | ||
| 400.798 | 5 | In distribution | |
| 421.546S | In distribution | ||
| 400.846 | 5 | In distribution | |
| 421.519 | In distribution | ||
| 400.846E | In distribution | ||
| 401.936E | In distribution | ||
| 421.506 | In distribution | ||
| 400.624E | In distribution | ||
| 446.040 | In distribution | ||
| 487.988 | In distribution | ||
| 421.522 | In distribution | ||
| 400.654 | 5 | In distribution | |
| 201.506 | In distribution | ||
| 420.031 | In distribution | ||
| SD480.111 | In distribution | ||
| 421.545 | In distribution | ||
| 446.18 | In distribution | ||
| 447.045 | In distribution | ||
| 447.405 | In distribution | ||
| 447.50 | In distribution | ||
| 446.014 | In distribution | ||
| 447.412 | In distribution | ||
| 395.65 | In distribution | ||
| 292.71 | 10 | In distribution | |
| 400.654E | In distribution | ||
| 395.67 | In distribution | ||
| 400.659 | 5 | In distribution | |
| 400.661E | In distribution | ||
| 449.651 | In distribution | ||
| 421.537 | In distribution | ||
| 401.816.96 | In distribution | ||
| 421.052 | In distribution | ||
| 447.034 | In distribution | ||
| 447.033 | In distribution | ||
| 447.304 | In distribution | ||
| 401.566E | In distribution | ||
| 497.668E | In distribution | ||
| 449.637 | In distribution | ||
| 421.049 | In distribution | ||
| 447.315 | In distribution | ||
| 449.004 | In distribution | ||
| 400.784E | In distribution | ||
| 288.026 | In distribution | ||
| 421.510 | In distribution | ||
| 400.629 | 5 | In distribution | |
| 401.312 | 5 | In distribution | |
| 421.546 | In distribution | ||
| 400.789E | In distribution | ||
| 447.150 | In distribution | ||
| 449.028 | In distribution | ||
| 288.019 | In distribution | ||
| 447.10 | In distribution | ||
| 288.039 | In distribution | ||
| 421.523 | In distribution | ||
| 401.172E | In distribution | ||
| 421.067 | In distribution | ||
| 446.614 | In distribution | ||
| 421.542 | In distribution | ||
| 449.04 | In distribution | ||
| 447.404 | In distribution | ||
| 401.564E | In distribution | ||
| 421.541S | In distribution | ||
| 400.662E | In distribution | ||
| 447.205 | In distribution | ||
| 449.05 | In distribution | ||
| 421.020 | In distribution | ||
| 401.520 | 5 | In distribution | |
| 447.049 | In distribution | ||
| 447.81 | In distribution | ||
| 400.794 | 5 | In distribution | |
| 447.011 | In distribution | ||
| 447.157 | In distribution | ||
| 421.532 | In distribution | ||
| 446.090 | In distribution | ||
| 401.526E | In distribution | ||
| 401.946 | 5 | In distribution | |
| 421.534 | In distribution | ||
| 447.076 | In distribution | ||
| 446.505 | In distribution | ||
| 400.790E | In distribution | ||
| 421.540S | In distribution | ||
| 288.059 | In distribution | ||
| 401.512E | In distribution | ||
| 401.939 | 5 | In distribution | |
| 446.782 | In distribution | ||
| 421.509 | In distribution | ||
| 421.102 | In distribution | ||
| 446.50 | In distribution | ||
| 446.509 | In distribution | ||
| 447.101 | In distribution | ||
| 447.22 | In distribution | ||
| 421.069 | In distribution | ||
| 449.110 | In distribution | ||
| 401.305E | In distribution | ||
| 449.018 | In distribution | ||
| 400.790 | 5 | In distribution | |
| 421.050 | In distribution | ||
| 447.317 | In distribution | ||
| 401.940 | 5 | In distribution | |
| 447.215 | In distribution | ||
| 447.206 | In distribution | ||
| 401.560 | 5 | In distribution | |
| 447.044 | In distribution | ||
| 401.528 | 5 | In distribution | |
| 446.796 | In distribution | ||
| 446.044 | In distribution | ||
| 446.22 | In distribution | ||
| 401.562 | 5 | In distribution | |
| 401.934E | In distribution | ||
| 449.008 | In distribution | ||
| 400.626 | 5 | In distribution | |
| 421.540 | In distribution | ||
| 446.507 | In distribution | ||
| 421.542S | In distribution | ||
| 447.425 | In distribution | ||
| 421.520 | In distribution | ||
| 400.658E | In distribution | ||
| 447.079 | In distribution | ||
| 401.318 | 5 | In distribution | |
| 421.534S | In distribution | ||
| 447.036 | In distribution | ||
| 447.156 | In distribution | ||
| 288.002 | In distribution | ||
| 401.544E | In distribution | ||
| 401.538 | 5 | In distribution | |
| 400.653E | In distribution | ||
| 400.844E | In distribution | ||
| 446.53 | In distribution | ||
| 449.638 | In distribution | ||
| 03.307.002 | In distribution | ||
| 421.547 | In distribution | ||
| 421.091 | In distribution | ||
| 447.111 | In distribution | ||
| 395.304 | In distribution | ||
| 421.543S | In distribution | ||
| 446.81 | In distribution | ||
| 400.658 | 5 | In distribution | |
| 421.081 | In distribution | ||
| 449.024 | In distribution | ||
| 449.38 | In distribution | ||
| 421.533 | In distribution | ||
| 401.509.96 | In distribution | ||
| 401.938 | 5 | In distribution | |
| 401.954E | In distribution | ||
| 447.077 | In distribution | ||
| 421.021 | In distribution | ||
| 487.987 | In distribution | ||
| 401.312E | In distribution | ||
| 288.001 | In distribution | ||
| 400.845E | In distribution | ||
| 446.40 | In distribution | ||
| 401.530 | 5 | In distribution | |
| 447.204 | In distribution | ||
| 449.632 | In distribution | ||
| 447.074 | In distribution | ||
| 421.531S | In distribution | ||
| 421.518 | In distribution | ||
| 487.984 | In distribution | ||
| 487.985 | In distribution | ||
| 447.039 | In distribution | ||
| 487.986 | In distribution | ||
| 421.104 | In distribution | ||
| 447.423 | In distribution | ||
| 447.140 | In distribution | ||
| 401.532 | 5 | In distribution | |
| 400.632 | 5 | In distribution | |
| 401.316E | In distribution | ||
| 447.153 | In distribution | ||
| 447.108 | In distribution | ||
| 450.101 | In distribution | ||
| 400.785E | In distribution | ||
| 401.832 | In distribution | ||
| 401.936 | 5 | In distribution | |
| 395.64 | In distribution | ||
| 446.052 | In distribution | ||
| 447.038 | In distribution | ||
| SD288.039 | In distribution | ||
| 421.531 | In distribution | ||
| 401.564 | 5 | In distribution | |
| 421.045S | In distribution | ||
| 421.008S | In distribution | ||
| 421.517 | In distribution | ||
| 401.542E | In distribution | ||
| 447.426 | In distribution | ||
| 447.051 | In distribution | ||
| 446.527 | In distribution | ||
| 447.082 | In distribution | ||
| 447.54 | In distribution | ||
| 447.013 | In distribution | ||
| 401.546E | In distribution | ||
| 447.055 | In distribution | ||
| 288.025 | In distribution | ||
| 421.535 | In distribution | ||
| 487.993 | In distribution | ||
| 421.080 | In distribution | ||
| 288.038 | In distribution | ||
| 401.508 | 5 | In distribution | |
| 401.157E | In distribution | ||
| 449.017 | In distribution | ||
| 449.636 | In distribution | ||
| 446.046 | In distribution | ||
| 401.942E | In distribution | ||
| 401.524 | 5 | In distribution | |
| 421.068 | In distribution | ||
| 421.539S | In distribution | ||
| 447.102 | In distribution | ||
| 400.854 | 5 | In distribution | |
| 447.103 | In distribution | ||
| 401.510 | 5 | In distribution | |
| 401.568E | In distribution | ||
| 447.119 | In distribution | ||
| 449.82 | In distribution | ||
| 400.836 | 5 | In distribution | |
| 447.212 | In distribution | ||
| 288.042 | In distribution | ||
| 400.785 | 5 | In distribution | |
| 446.053 | In distribution | ||
| 421.533S | In distribution | ||
| 421.535S | In distribution | ||
| 400.638 | 5 | In distribution | |
| SD288.043 | In distribution | ||
| 400.787 | 5 | In distribution | |
| 421.008 | In distribution | ||
| 487.980 | In distribution | ||
| 447.158 | In distribution | ||
| 401.510.96 | In distribution | ||
| 401.514.96 | 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 |
| OsteoMed | Osteomed | 675 |
| Bioplate® | Bioplate, Inc. | 669 |
| 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 |
|---|---|
| K122647 | 2013-02-28 |
| K113567 | 2012-11-19 |
| K121574 | 2012-06-29 |
| K113251 | 2011-12-21 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2015-07-29 | Class II | Labeling design | Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR | 5306080 | 2016-09-27 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-01-11 | Class II | Employee error | There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized. | 596 | 2015-08-31 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-06-18 | Class II | Under Investigation by firm | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched “4”, which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw. | 104 units | 2021-04-13 |
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.