GDLH VARIABLE ANGLE CONNECTOR— 510(k) K934582

Substantially Equivalent for Some Indications

Danek Group, Inc.

FDA 510(k) clearance K934582 for GDLH VARIABLE ANGLE CONNECTOR, Substantially Equivalent for Some Indications on 1994-06-21. Applicant: Danek Group, Inc..

Clearance details

Applicant: Danek Group, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1993-09-23
Decision date: 1994-06-21
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.