Sterngold/Implamed · Class II · Cleared May 11, 1998
| K-number | K981516 |
| Device name | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB |
| Applicant | Sterngold/Implamed |
| Product code | DZE |
| Device class | Class II |
| Decision date | May 11, 1998 |
| Decision | Substantially Equivalent |
| Regulation | 872.3640 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov