Trabecular Metal™
2 catalogue numbers from 00-5451-013-68, listed by Zimmer Trabecular Metal Technology, Inc., United States, under Instrument, Cranioplasty Material Forming. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
Record
| Listed by | Zimmer Trabecular Metal Technology, Inc., United States |
|---|---|
| FDA product code | HBX |
| Device type | Instrument, Cranioplasty Material Forming |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4500 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K102896 |
| Record published | 2016-05-24 |
| Record revised | 2023-05-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-5451-013-68 | 67 MM x 38 MM | In distribution |
| 00-5451-013-52 | 51 MM x 34 MM | In distribution |
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.