Back 2 Basics Direct LLC

FDA Regulatory Profile

Back 2 Basics Direct LLC appears in FDA public data with 1 recall, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2881-2018, Class II) was initiated on June 29, 2018. Its most recent 510(k) clearance was granted on May 12, 2020.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2881-2018Class IIDymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The DymaJune 29, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K192930Dymaxeon Spine SystemMay 12, 2020
K191537eCarbon IBDsSeptember 26, 2019
K170989Dymaxeon Spine SystemMay 22, 2017
K150184Dymaxeon Spine SystemJune 15, 2015