REPOSE BONE SCREW SYSTEM— 510(k) K981677

Substantially Equivalent

Influence, Inc.

FDA 510(k) clearance K981677 for REPOSE BONE SCREW SYSTEM, Substantially Equivalent on 1999-08-27. Applicant: Influence, Inc..

Clearance details

Applicant: Influence, Inc.
Product code: Code LRK
Advisory panel: Dental
Date received: 1998-05-12
Decision date: 1999-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.