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Orthomerica Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
21
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240466STARband 3DMarch 15, 2024
K223238STARband 3DApril 20, 2023
K211376STARbandAugust 17, 2021
K203098STARband, STARlight, St. Louis BandApril 27, 2021
K180109STARband, STARlight, St. Louis BandMarch 1, 2018
K161138St. Louis BandJuly 20, 2016
K151979STARband, STARlightSeptember 18, 2015
K151147STARband, STARlightJuly 1, 2015
K142141STARBAND, STARLIGHTApril 23, 2015
K141842STARBAND, STARLIGHTOctober 6, 2014
K140353STARBAND AND STARLIGHTJune 6, 2014
K133250STARLIGHTJanuary 16, 2014
K124023STARBANDJune 10, 2013
K090587STARLIGHTJuly 17, 2009
K082950STARBANDDecember 5, 2008
K082945STARLIGHTOctober 31, 2008
K081994STARLIGHTSeptember 12, 2008
K021918CLARREN HELMET (ORTHOMERICA)July 25, 2002
K021207STARLIGHTJuly 9, 2002
K011350STARBAND CRANIAL ORTHOSISJuly 3, 2001