STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB— 510(k) K981516

Substantially Equivalent

Sterngold/Implamed

FDA 510(k) clearance K981516 for STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB, Substantially Equivalent on 1998-05-11. Applicant: Sterngold/Implamed.

Clearance details

Applicant: Sterngold/Implamed
Product code: Code DZE
Advisory panel: Dental
Date received: 1998-04-28
Decision date: 1998-05-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Attleboro, MA, US

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Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.