Valeris Medical, LLC

FDA Regulatory Profile

Valeris Medical, LLC appears in FDA public data with 2 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0104-2019, Class II) was initiated on July 16, 2018. Its most recent 510(k) clearance was granted on March 26, 2020.

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0104-2019Class IIValeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contaJuly 16, 2018
Z-2430-2018Class IIApollo XT Suture Anchor, 5.5 x 15 Product Usage: Apollo XT Suture Anchors are intended for: ShouJanuary 22, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K193108Bonecam Suture AnchorMarch 26, 2020
K192810Apollo Suture Anchor SystemMarch 11, 2020
K152255BoneCam Suture AnchorsNovember 16, 2015
K142230Apollo Suture Anchor System and Titan ScrewsSeptember 10, 2014