Acute QC Strut and Components
HA Half PIN Washer 2MM
3manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
1recall
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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | OSN |
| Device type | Software For Diagnosis/Treatment |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K221792 |
| Record published | 2022-09-07 |
| Record revised | 2023-09-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 71935869 | In distribution | ||
| 71935872 | 5 | In distribution | |
| 71935867 | In distribution | ||
| 71935868 | In distribution | ||
| 71935873 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Software For Diagnosis/Treatment | Synthes Gmbh | 108 |
| Maxframe | Synthes Gmbh | 27 |
| Orthofix TrueLok Hexapod System (TL-HEX) V2.0 | Orthofix SRL | 27 |
| Arthrex® | Arthrex, Inc. | 21 |
| Maxframe | Synthes (U.S.A.) LP | 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221792 | 2022-08-25 |
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 |
|---|---|---|---|---|---|
| 2017-12-13 | Class II | Under Investigation by firm | In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted in the preview images on the Strut Settings tab. | N/A | 2020-10-05 |
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.