Anterior Column Plate, Left
Anterior Column Plate, Left, 14-Hole, PRS RX System
22manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
16recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | I.T.S. Gmbh, Austria |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2017-02-01 |
| Record revised | 2026-06-22 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21218-14 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260958 | 2026-06-16 |
| K260054 | 2026-04-24 |
| K210935 | 2022-08-31 |
| K142418 | 2014-09-26 |
| K131722 | 2013-08-07 |
| K130008 | 2013-06-25 |
Recalls
16 of these are Class II. Class II means a temporary or reversible health consequence. 15 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 70 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 292 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 15,517 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 4 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 11 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 46,637 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 120 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 322 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 101 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 1,307 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 176 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 510 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 220 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 12,059 units |
| 2026-01-23 | Class II | No Marketing Application | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | 869 units |
| 2019-05-09 | Class II | Labeling mix-ups | The titanium implant has the wrong article number laser marked on it. | 65 devices |
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.