K121304 is an FDA 510(k) clearance for the OSTEOMED CRANIAL DISTRACTION SYSTEM. This device is classified as a Cranial Distraction System (Class II - Special Controls, product code PBJ).
Submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on August 22, 2012, 113 days after receiving the submission on May 1, 2012.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5330. A Cranial Distraction System Is A Metal Device Intended To Establish Osteodistraction And Bone Growth In The Skull. The Bone Segments Are Attached To The Plate With Screws To Prevent Movement Of The Segments..
| 510(k) Number | K121304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 01, 2012 |
| Decision Date | August 22, 2012 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PBJ - Cranial Distraction System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5330 |
| Definition | A Cranial Distraction System Is A Metal Device Intended To Establish Osteodistraction And Bone Growth In The Skull. The Bone Segments Are Attached To The Plate With Screws To Prevent Movement Of The Segments. |