SILHOUETTE SPINAL FIXATION SYSTEM— 510(k) K993067

Substantially Equivalent

Sulzer Spine-Tech

FDA 510(k) clearance K993067 for SILHOUETTE SPINAL FIXATION SYSTEM, Substantially Equivalent on 1999-11-16. Applicant: Sulzer Spine-Tech.

Clearance details

Applicant: Sulzer Spine-Tech
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1999-09-13
Decision date: 1999-11-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, 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.