PARAGON POSTERIOR SPINAL SYSTEM— 510(k) K920546

Substantially Equivalent for Some Indications

Sofamor Danek Mfg., Inc.

FDA 510(k) clearance K920546 for PARAGON POSTERIOR SPINAL SYSTEM, Substantially Equivalent for Some Indications on 1993-01-21. Applicant: Sofamor Danek Mfg., Inc..

Clearance details

Applicant: Sofamor Danek Mfg., Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1992-02-06
Decision date: 1993-01-21
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.