510(k) Report

Devices descending from K063395

5 later devices reach O&P Bivalve Cranial Molding Helmet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161138St. Louis BandOrthomerica Products, Inc.20164—
+2K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.20183—
+3K213587MyCRO BandOtto Bock Healthcare LP20220—
+3K193383SnugKapHeadstart, Ltd.20210—
+3K201426MyCRO BandOtto Bock Healthcare LP20210—