K161138 is an FDA 510(k) clearance for the St. Louis Band. This device is classified as a Orthosis, Cranial, Laser Scan (Class II - Special Controls, product code OAN).
Submitted by Orthomerica Products, Inc. (Orlando, US). The FDA issued a Cleared decision on July 20, 2016, 89 days after receiving the submission on April 22, 2016.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5970. 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 Infant's Head. Indicated For Infants From 3 To 18 Months Of Age, With Moderate To Severe Nonsynostotic Positional Plagiocephaly, Including Infants With Plagiocephalic-, Brachycephalic-, And Scaphocephalic-shaped Heads..
| 510(k) Number | K161138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 2016 |
| Decision Date | July 20, 2016 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | OAN — Orthosis, Cranial, Laser Scan |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5970 |
| 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 Infant's Head. Indicated For Infants From 3 To 18 Months Of Age, With Moderate To Severe Nonsynostotic Positional Plagiocephaly, Including Infants With Plagiocephalic-, Brachycephalic-, And Scaphocephalic-shaped Heads. |