EXCELLA-M SPINAL SYSTEM— 510(k) K042143

Substantially Equivalent

Innovasis, Inc.

FDA 510(k) clearance K042143 for EXCELLA-M SPINAL SYSTEM, Substantially Equivalent on 2004-10-07. Applicant: Innovasis, Inc..

Clearance details

Applicant: Innovasis, Inc.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2004-08-09
Decision date: 2004-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.