510(k) Report

Devices descending from DEN980001

33 later devices reach Dynamic Orthotic Cranioplasty Band; Doc Band through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K244056DOC Band 3DCranial Technologies, Inc.20250—
+1K042385Doc Band-PostopCranial Technologies, Inc.20041—
+1K021594Copc BandCenter For Orthotic and Prosthetic Care,Llc20030—
+1K020448Static Cranioplasty OrthosisEastern Cranial Affiliates20022—
+1K013719Becker Band Cranial Remolding OrthosisBecker Orthopedic Appliance Co.20020—
+1K013700Orthosis Helmet MoldingPrecision Prosthetics & Orthotics, Inc.20026—
+1K014012Doc BandCranial Technologies, Inc.200221—
+1K012804Plagiocephalic Applied Pressure Orthosis P.a.P. OrthosisScott E Allen CP20021—
+1K012920Molded Cranial HelmetFairview Orthopedic Laboratory20011—
+2K193383SnugKapHeadstart, Ltd.20210—
+2K180568KidCapEastern Cranial Affiliates, LLC20181—
+2K140353Starband and StarlightOrthomerica Products, Inc.201413—
+2K072566Hanger Cranial BandHanger Prosthetics & Orthotics, Inc.200820—
+2K063395O&P Bivalve Cranial Molding HelmetOrthotic & Prosthetic Lab, Inc.20065—
+2K041215Cranial HelmetOtto Bock Healthcare LP20040—
+3K203134Hanger Cranial Band 3DSymbion Logistics, LLC20220—
+3K161138St. Louis BandOrthomerica Products, Inc.20164—
+3K142141Starband, StarlightOrthomerica Products, Inc.20151—
+3K141842Starband, StarlightOrthomerica Products, Inc.201410—
+3K133397P-PODP-Pod20141—
+3K111609Boston BandBoston Brace Intl., Inc.201116—
+3K090341Michigan Cranial Reshaping OrthosisDanmar Products, Inc.20100—
+4K203098STARband, STARlight, St. Louis BandOrthomerica Products, Inc.20210—
+4K180109STARband, STARlight, St. Louis BandOrthomerica Products, Inc.20183—
+4K151147STARband, STARlightOrthomerica Products, Inc.20159—
+4K124023StarbandOrthomerica Products, Inc.201315—
+5K213587MyCRO BandOtto Bock Healthcare LP20220—
+5K201426MyCRO BandOtto Bock Healthcare LP20210—
+5K151979STARband, STARlightOrthomerica Products, Inc.20158—
+5K133250StarlightOrthomerica Products, Inc.201414—
+6K220681Talee, Talee PostOPInvent Medical USA, LLC20222—
+7K230444Talee, Talee PostOpInvent Medical USA, LLC20231—
+8K241957Talee, Talee PostOpInvent Medical USA, LLC20240—