DeviceClearance

Juliet® Ti LL Lumbar Interbody Device— 510(k) K190877

Substantially Equivalent

Spineart

FDA 510(k) clearance K190877 for Juliet® Ti LL Lumbar Interbody Device, Substantially Equivalent on 2019-05-29. Applicant: Spineart. Device class: 2.

Clearance details

Applicant
Spineart
Product code
Code OVD
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Plan Les Ouates, CH
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OVD

product code OVD
Death
5
Injury
495
Total
500

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 →

Recalls naming K190877

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190877.

Data sourced from openFDA. This site is unofficial and independent of the FDA.