DeviceClearance

PRIMA TT Glenoid— 510(k) K222427

Substantially Equivalent

Lima Corporate S.P.A.

FDA 510(k) clearance K222427 for PRIMA TT Glenoid, Substantially Equivalent on 2022-10-06. Applicant: Lima Corporate S.P.A.. Device class: 2.

Clearance details

Applicant
Lima Corporate S.P.A.
Product code
Code MBF
Device class
Class 2
Regulation
21 CFR 888.3670
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Villanova Di San Daniele Del Friuli, IT
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MBF

product code MBF
Injury
597
Total
597

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 K222427

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 K222427.

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