Serf

FDA Regulatory Profile

Serf appears in FDA public data with 0 recalls, 4 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent FDA inspection ended on Jan 30, 2025 (No Action Indicated (NAI)). Its most recent 510(k) clearance was granted on Dec 22, 2023.

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Summary

Total Recalls
0
510(k) Clearances
4
Inspections
3
Compliance Actions
0

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 30, 2025Decines-Charpieu, FranceDevicesNo Action Indicated (NAI)3008668801
Sep 21, 2017Decines-Charpieu, FranceDevicesVoluntary Action Indicated (VAI)3008668801
Jun 20, 2013Decines-Charpieu, FranceDevicesVoluntary Action Indicated (VAI)3008668801

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).

Recent 510(k) Clearances

K-NumberDeviceDate
K223745Novae® Dual Mobility System, Hype® Hip SystemDec 22, 2023
K181744BI-MENTUM dual mobility systemDec 11, 2018
K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupJan 15, 2015
K111572NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY…Aug 29, 2011