510(k) Report

Devices descending from K011350

31 later devices reach Starband Cranial Orthosis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111247Cranial Remolding OrthosisOrthotic Care Services, Llp20110—
+1K081787Camlab Cranial Orthosis HelmetBiosculptor Corporation200916—
+1K082950StarbandOrthomerica Products, Inc.200821—
+1K072862Boston-Band Cranial Remodling OrthosisBoston Brace Intl., Inc.200818—
+1K063098Static Cranioplasty OrthosisBoston Brace Intl., Inc.20070—
+1K021221O&P Cranical Molding HelmetOrthotic & Prosthetic Lab, Inc.20020—
+1K014012Doc BandCranial Technologies, Inc.200221—
+2K211376STARbandOrthomerica Products, Inc.20212—
+2K140353Starband and StarlightOrthomerica Products, Inc.201413—
+2K124023StarbandOrthomerica Products, Inc.201315—
+2K111609Boston BandBoston Brace Intl., Inc.201116—
+2K090341Michigan Cranial Reshaping OrthosisDanmar Products, Inc.20100—
+2K072566Hanger Cranial BandHanger Prosthetics & Orthotics, Inc.200820—
+3K223238STARband 3DOrthomerica Products, Inc.20231—
+3K203134Hanger Cranial Band 3DSymbion Logistics, LLC20220—
+3K142141Starband, StarlightOrthomerica Products, Inc.20151—
+3K141842Starband, StarlightOrthomerica Products, Inc.201410—
+3K133397P-PODP-Pod20141—
+3K133250StarlightOrthomerica Products, Inc.201414—
+4K240466STARband 3DOrthomerica Products, Inc.20240—
+4K193383SnugKapHeadstart, Ltd.20210—
+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—
+7K201426MyCRO BandOtto Bock Healthcare LP20210—
+8K241957Talee, Talee PostOpInvent Medical USA, LLC20240—