SCS SPINAL SYSTEM— 510(k) K983353

Substantially Equivalent

Orthotec, Inc.

FDA 510(k) clearance K983353 for SCS SPINAL SYSTEM, Substantially Equivalent on 1998-12-18. Applicant: Orthotec, Inc..

Clearance details

Applicant: Orthotec, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1998-09-23
Decision date: 1998-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hill, CA, US

Download summary PDF View on FDA.gov ↗

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.