2 catalogue numbers from SSI005873, listed by Zimmer, Inc., United States, under Punch, Femoral Neck. 4 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Prem Cruciate Punch | Listed by | Zimmer, Inc., United States |
| FDA product code | HWP |
| Device type | Punch, Femoral Neck |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-08 |
| Record revised | 2021-10-19 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
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.