K052247

Substantially Equivalent

NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX

Applicant
Abbott Spine, Inc.
Product code
KWP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Austin, TX, 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, through . 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.