MCI – Medical Concept Innovation, Inc.
12MM Offset Angled Piriformis Micro Plate #0.6MM Right
3manufacturers in China registered for this device type
117catalogue numbers in this listing
1510(k) clearance
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 | MCI Medical Concept Innovation Inc., United States |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K212391 |
| Record published | 2023-06-14 |
| Record revised | 2025-06-09 (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, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A01.02.1105 | In distribution | |
| A01.01.1012 | In distribution | |
| A01.01.2495 | In distribution | |
| A01.01.2014 | In distribution | |
| A01.01.2311 | In distribution | |
| A01.01.1018 | In distribution | |
| A01.01.1287 | In distribution | |
| A01.01.4054 | In distribution | |
| A01.01.2028 | In distribution | |
| A01.01.1267 | In distribution | |
| A01.02.1125 | In distribution | |
| A01.01.1346 | In distribution | |
| A01.01.2077 | In distribution | |
| A01.01.2263 | In distribution | |
| A01.01.1138 | In distribution | |
| A01.01.1269 | In distribution | |
| A01.01.2363 | In distribution | |
| A01.02.1128 | In distribution | |
| A01.01.2305 | In distribution | |
| A01.01.2015 | In distribution | |
| A01.01.2075 | In distribution | |
| A01.01.1401 | In distribution | |
| A01.02.1110 | In distribution | |
| A01.01.1104 | In distribution | |
| A01.01.1000 | In distribution | |
| A01.02.1100 | In distribution | |
| A01.01.2101 | In distribution | |
| A01.01.2012 | In distribution | |
| A01.01.1330 | In distribution | |
| A01.01.1090 | In distribution | |
| A01.01.1020 | In distribution | |
| A01.01.1137 | In distribution | |
| A01.01.1099 | In distribution | |
| A01.01.4023 | In distribution | |
| A01.02.1101 | In distribution | |
| A01.01.4022 | In distribution | |
| A01.01.1021 | In distribution | |
| A01.02.1111 | In distribution | |
| A01.01.1089 | In distribution | |
| A01.02.1112 | In distribution | |
| A01.01.2617 | In distribution | |
| A01.01.1100 | In distribution | |
| A01.01.2008 | In distribution | |
| A01.02.1161 | In distribution | |
| A01.02.1004 | In distribution | |
| A01.01.1291 | In distribution | |
| A01.01.1153 | In distribution | |
| A01.01.2016 | In distribution | |
| A01.01.1147 | In distribution | |
| A01.01.2351 | In distribution | |
| A01.01.2310 | In distribution | |
| A01.01.1336 | In distribution | |
| A01.01.2027 | In distribution | |
| A01.02.1115 | In distribution | |
| A01.01.4076 | In distribution | |
| A01.02.1113 | In distribution | |
| A01.01.1335 | In distribution | |
| A01.02.1011 | In distribution | |
| A01.01.1139 | In distribution | |
| A01.01.1091 | In distribution | |
| A01.02.1109 | In distribution | |
| A01.02.1127 | In distribution | |
| A01.01.2389 | In distribution | |
| A01.01.2360 | In distribution | |
| A01.01.2387 | In distribution | |
| A01.01.1266 | In distribution | |
| A01.01.1006 | In distribution | |
| A01.01.2302 | In distribution | |
| A01.02.1013 | In distribution | |
| A01.01.2371 | In distribution | |
| A01.01.2300 | In distribution | |
| A01.01.2103 | In distribution | |
| A01.01.1022 | In distribution | |
| A01.01.4020 | In distribution | |
| A01.01.1273 | In distribution | |
| A01.01.1292 | In distribution | |
| A01.02.1123 | In distribution | |
| A01.01.1019 | In distribution | |
| A01.02.1012 | In distribution | |
| A01.01.1095 | In distribution | |
| A01.02.1114 | In distribution | |
| A01.01.1148 | In distribution | |
| A01.01.1144 | In distribution | |
| A01.01.2002 | In distribution | |
| A01.01.1092 | In distribution | |
| A01.01.1328 | In distribution | |
| A01.01.1004 | In distribution | |
| A01.01.2374 | In distribution | |
| A01.01.2309 | In distribution | |
| A01.02.1103 | In distribution | |
| A01.01.1396 | In distribution | |
| A01.01.1017 | In distribution | |
| A01.01.2303 | In distribution | |
| A01.01.2000 | In distribution | |
| A01.01.3010 | In distribution | |
| A01.01.1345 | In distribution | |
| A01.01.1000 | In distribution | |
| A01.01.1002 | In distribution | |
| A01.01.1248 | In distribution | |
| A01.01.2301 | In distribution | |
| A01.01.1103 | In distribution | |
| A01.01.2155 | In distribution | |
| A01.02.1108 | In distribution | |
| A01.01.1271 | In distribution | |
| A01.01.2352 | In distribution | |
| A01.02.1107 | In distribution | |
| A01.01.1096 | In distribution | |
| A01.01.1397 | In distribution | |
| A01.01.2107 | In distribution | |
| A01.02.1106 | In distribution | |
| A01.01.2919 | In distribution | |
| A01.01.1249 | In distribution | |
| A01.01.1145 | In distribution | |
| A01.01.2307 | In distribution | |
| A01.02.1000 | In distribution | |
| A01.01.2026 | In distribution | |
| A01.02.1129 | In distribution |
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 |
|---|---|
| K182758 | 2019-12-05 |
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.