Maxframe
Maxframe Autostrut(TM) Automat Hexapod Ctrl SYS KIT-Bluetoot
3manufacturers in China registered for this device type
27catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (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 |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| YU XIN Technology(Huizhou) Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 5 |
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | OSN |
| Device type | Software For Diagnosis/Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K051600 |
| Record published | 2021-07-20 |
| Record revised | 2026-06-24 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -30 to 60 °C; Handling environment temperature 5 to 40 °C; Special storage condition: Do not use if pkg is damaged |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03.313.866 | In distribution | |
| 03.314.100 | In distribution | |
| 03.313.381 | In distribution | |
| 03.313.865 | In distribution | |
| 03.312.004 | In distribution | |
| 03.313.857 | In distribution | |
| 03.313.879 | In distribution | |
| 03.313.867 | In distribution | |
| 03.313.870 | In distribution | |
| 03.313.860 | In distribution | |
| 03.314.000 | In distribution | |
| 03.314.001 | In distribution | |
| 03.313.855 | In distribution | |
| 03.313.211 | In distribution | |
| 03.313.864 | In distribution | |
| 03.313.351 | In distribution | |
| 03.313.868 | In distribution | |
| 03.313.873 | In distribution | |
| 03.312.005 | In distribution | |
| 03.313.859 | In distribution | |
| 03.313.885 | In distribution | |
| 03.312.002 | In distribution | |
| 03.312.003 | In distribution | |
| 03.312.000 | In distribution | |
| 03.313.884 | In distribution | |
| 03.313.880 | In distribution | |
| 03.313.877 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Software For Diagnosis/Treatment | Synthes Gmbh | 108 |
| Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix SRL | 27 |
| Arthrex® | Arthrex, Inc. | 21 |
| Maxframe | Synthes (U.S.A.) LP | 5 |
| Acute QC Strut and Components | Smith & Nephew, Inc. | 5 |
| True Lok System | Orthofix SRL | 3 |
| Smart TSF | Smith & Nephew, Inc. | 3 |
| Orthex | Vilex IN Tennessee, Inc. | 1 |
| Enos Software Guided External Fixation System | Disior OY | 1 |
| Orthex External Fixation System | Orthopediatrics, Corp | 1 |
| Smart Correction | Wishbone Medical Inc. | 1 |
| Orthex | Orthopediatrics, Corp | 1 |
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 Gmbh | 510(k) number | 2014-04-10 | Class II | Labeling Change Control | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. | 5,114,052 | 2016-08-26 |
| Synthes Spine | 510(k) number | 2009-02-09 | Not classified | Process control | Numbers are etched incorrectly on the product. | 1,137 units | 2009-12-15 |
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.