K240872

Substantially Equivalent

Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System

Applicant
Clariance
Product code
NKB
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Beaurains, FR
Download summary PDF View on FDA.gov ↗

Adverse events under product code NKB

product code NKB
Death
27
Injury
5,033
Malfunction
4,140
Total
9,200

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.