The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for Sterngold Implamed Hex Screw Implant Tps Coated Sterngold Implamed Hex Screw Implant Ha Coated , Refer To Table 1 In Sub.
| Device ID | K981516 |
| 510k Number | K981516 |
| Device Name: | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERNGOLD/IMPLAMED 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967 |
| Contact | Karen Hickey |
| Correspondent | Karen Hickey STERNGOLD/IMPLAMED 23 FRANK MOSSBERG DR. Attleboro, MA 02703 -0967 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-28 |
| Decision Date | 1998-05-11 |