K102248

Substantially Equivalent

EXCELLA II SPINAL SYSTEM MODEL EC2-00

Applicant: Innovasis, Inc.
Product code: NKB
Advisory panel: Orthopedic
Date received: 2010-08-09
Decision date: 2010-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

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.