510(k) Report

Devices descending from K081787

16 later devices reach Camlab Cranial Orthosis Helmet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K124023StarbandOrthomerica Products, Inc.201315—
+2K140353Starband and StarlightOrthomerica Products, Inc.201413—
+2K133250StarlightOrthomerica Products, Inc.201414—
+3K142141Starband, StarlightOrthomerica Products, Inc.20151—
+3K141842Starband, StarlightOrthomerica Products, Inc.201410—
+4K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.20210—
+4K151147STARband, STARlightOrthomerica Products, Inc.20159—
+5K151979STARband, STARlightOrthomerica Products, Inc.20158—
+6K220681Talee, Talee PostOPInvent Medical USA, LLC20222—
+6K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.20183—
+6K161138St. Louis BandOrthomerica Products, Inc.20164—
+7K230444Talee, Talee PostOpInvent Medical USA, LLC20231—
+7K213587MyCRO BandOtto Bock Healthcare LP20220—
+7K193383SnugKapHeadstart, Ltd.20210—
+7K201426MyCRO BandOtto Bock Healthcare LP20210—
+8K241957Talee, Talee PostOpInvent Medical USA, LLC20240—