SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM— 510(k) K042508

Substantially Equivalent

Depuy Spine, Inc.

FDA 510(k) clearance K042508 for SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM, Substantially Equivalent on 2004-10-07. Applicant: Depuy Spine, Inc..

Clearance details

Applicant: Depuy Spine, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2004-09-15
Decision date: 2004-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, 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.