FlexitSystem
Opening wedge HTO Symmetrical Plate Size 2
22manufacturers in China registered for this device type
17catalogue numbers in this listing
1510(k) clearance
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 | Neosteo, France |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K212545 |
| Record published | 2022-05-02 |
| Record revised | 2024-02-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 25 °C; Special storage condition: Device must be stored in a place protected from light and humidity. |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S02TL75 | Diameter 5mm, Length 75mm | In distribution |
| S02TL80 | Diameter 5mm, Length 80mm | In distribution |
| PTS001-7 | Number of holes: 7, Length 80mm, Nominal Thickness 3mm, Side of implantation: No | In distribution |
| S02TL35 | Diameter 5mm, Length 35mm | In distribution |
| S02TL70 | Diameter 5mm, Length 70mm | In distribution |
| S02TL60 | Diameter 5mm, Length 60mm | In distribution |
| S02TL65 | Diameter 5mm, Length 65mm | In distribution |
| S02TL45 | Diameter 5mm, Length 45mm | In distribution |
| PTS003-10 | Number of holes: 10, Length 88mm, Nominal Thickness 3,5mm, Side of implantation: No | In distribution |
| PTS001-6 | Number of holes: 6, Length 63mm, Nominal Thickness 3mm, Side of implantation: No | In distribution |
| PTL002-6 | Number of holes: 6, Length 63mm, Nominal Thickness 3,2mm, Side of implantation: Left | In distribution |
| S02TL40 | Diamater 5mm, Length 40mm | In distribution |
| S02TL55 | Diameter 5mm, Length 55mm | In distribution |
| S02TL50 | Diameter 5mm, Length 50mm | In distribution |
| PTR002-6 | Number of holes: 6, Length 63mm, Nominal Thickness 3,2mm, Side of implantation: Right | In distribution |
| S02TL25 | Diameter 5mm, Length 25mm | In distribution |
| S02TL30 | Diameter 5mm, Lenght 30mm | 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 |
|---|---|
| K212545 | 2022-02-11 |
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.