Definition: A Cranial Orthosis Is A Device That Is Intended For Medical Purposes To Apply Pressure To Prominent Regions Of An Infant's Cranium In Order To Improve Cranial Symmetry And/or Shape. A Laser Scanning Accessory May Be Used To Create A Scan Of The Infan
| Device Type ID | 3759 |
| Device Name | Orthosis, Cranial, Laser Scan |
| Physical State | Cranial Orthotics Are Custom-made For Each Patient's Head. They Are Typically Made From Plastics, Foam And Velcro. |
| Technical Method | A Mold Is Made Of The Baby's Head To Create The Orthotic. Plaster Or Laser Scanning May Be Used To Create The Mold. |
| Target Area | Infant Craniums |
| Regulation Description | Cranial Orthosis. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5970 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OAN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3759 |
| Device | Orthosis, Cranial, Laser Scan |
| Product Code | OAN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cranial Orthosis. |
| CFR Regulation Number | 882.5970 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ORTHOMERICA PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |