510(k) Report

Devices descending from K001167

31 later devices reach Opi Band through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103362Aoi Cranial HelmetAdvanced Orthopro, Inc.20110—
+1K021207StarlightOrthomerica Products, Inc.200225—
+1K013719Becker Band Cranial Remolding OrthosisBecker Orthopedic Appliance Co.20020—
+1K012804Plagiocephalic Applied Pressure Orthosis P.a.P. OrthosisScott E Allen CP20021—
+1K012830Lerman & Son Cranial Orthosis HelmetLerman & Son20010—
+2K081994StarlightOrthomerica Products, Inc.200824—
+2K041215Cranial HelmetOtto Bock Healthcare LP20040—
+3K082950StarbandOrthomerica Products, Inc.200821—
+3K082945StarlightOrthomerica Products, Inc.200816—
+4K211376STARbandOrthomerica Products, Inc.20212—
+4K124023StarbandOrthomerica Products, Inc.201315—
+4K111609Boston BandBoston Brace Intl., Inc.201116—
+4K111247Cranial Remolding OrthosisOrthotic Care Services, Llp20110—
+4K090587StarlightOrthomerica Products, Inc.200915—
+5K223238STARband 3DOrthomerica Products, Inc.20231—
+5K140353Starband and StarlightOrthomerica Products, Inc.201413—
+5K133250StarlightOrthomerica Products, Inc.201414—
+6K240466STARband 3DOrthomerica Products, Inc.20240—
+6K142141Starband, StarlightOrthomerica Products, Inc.20151—
+6K141842Starband, StarlightOrthomerica Products, Inc.201410—
+7K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.20210—
+7K151147STARband, STARlightOrthomerica Products, Inc.20159—
+8K151979STARband, STARlightOrthomerica Products, Inc.20158—
+9K220681Talee, Talee PostOPInvent Medical USA, LLC20222—
+9K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.20183—
+9K161138St. Louis BandOrthomerica Products, Inc.20164—
+10K230444Talee, Talee PostOpInvent Medical USA, LLC20231—
+10K213587MyCRO BandOtto Bock Healthcare LP20220—
+10K193383SnugKapHeadstart, Ltd.20210—
+10K201426MyCRO BandOtto Bock Healthcare LP20210—
+11K241957Talee, Talee PostOpInvent Medical USA, LLC20240—