BIORIGID NAIL TIBIA— 510(k) K970013

Substantially Equivalent

Aap GmbH and Co. Betriebs KG

FDA 510(k) clearance K970013 for BIORIGID NAIL TIBIA, Substantially Equivalent on 1997-03-13. Applicant: Aap GmbH and Co. Betriebs KG.

Clearance details

Applicant: Aap GmbH and Co. Betriebs KG
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 1997-01-02
Decision date: 1997-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 12099 Berlin, DE

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Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

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.