Peri-LOC
Peri-LOC Cable Saddle Short Titanium
2manufacturers in China registered for this device type
3catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | JDO |
| Device type | Device, Fixation, Proximal Femoral, Implant |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K080434 |
| Record published | 2015-08-29 |
| Record revised | 2025-08-01 (version 10) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71863475 | In distribution | |
| 71863477 | In distribution | |
| 71863476 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BMP Compression HIP Screw | Biomet Orthopedics | 112 |
| DHS | Synthes Gmbh | 93 |
| THP™ Hip Fracture Plating System | Biomet Orthopedics | 74 |
| Percutaneous Compression Plate (Pc.c.p) | Orthofix SRL | 69 |
| Proform Hip System | Globus Medical, Inc. | 51 |
| Conquest FN | Smith & Nephew, Inc. | 31 |
| CHS | Smith & Nephew, Inc. | 26 |
| Large Cannulated Screws | Smith & Nephew, Inc. | 22 |
| TSP HIP FX Plating SYSTEM4.5MM Cortical NON – Locking Screw | Biomet Orthopedics | 13 |
| TSP HIP FX Plating SYSTEM4.5MM Cortical Locking Screw | Biomet Orthopedics | 12 |
| TSP HIP FX Plating SYSTEM7.5MM Telescoping LAG Screw | Biomet Orthopedics | 6 |
| Dhhs | Synthes Gmbh | 6 |
Showing 12 of 112. All products under Device, Fixation, Proximal Femoral, Implant
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213126 | 2022-09-29 |
| K193029 | 2020-02-28 |
| K172785 | 2017-12-22 |
| K152686 | 2016-03-17 |
| K080434 | 2008-04-10 |
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.