Clearance Summary
STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB received FDA 510(k) clearance under submission number K981516, sponsored by Sterngold/Implamed. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1998-05-11.
- Submission: K981516
- Applicant / Sponsor: Sterngold/Implamed
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3640
- Decision date: 1998-05-11
Classification & Regulation
This clearance is catalogued under FDA product code DZE and 21 CFR 872.3640, within the Dental review panel as a Class II device.