510(k) Report

Devices descending from K013700

6 later devices reach Orthosis Helmet Molding through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063395O&P Bivalve Cranial Molding HelmetOrthotic & Prosthetic Lab, Inc.20065—
+2K161138St. Louis BandOrthomerica Products, Inc.20164—
+3K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.20183—
+4K213587MyCRO BandOtto Bock Healthcare LP20220—
+4K193383SnugKapHeadstart, Ltd.20210—
+4K201426MyCRO BandOtto Bock Healthcare LP20210—