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.
| Device Type ID | 3779 |
| Device Name | Cranial Distraction System |
| Physical State | May Include: Distractors, Distraction Plates, Spacers, Screws And Instrumentation |
| Technical Method | Bone Segments Are Attached To The Plate With Screws To Prevent Movement Of The Segments. |
| Target Area | Cranium, Skull |
| Regulation Description | Preformed Nonalterable Cranioplasty Plate. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PBJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3779 |
| Device | Cranial Distraction System |
| Product Code | PBJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Preformed Nonalterable Cranioplasty Plate. |
| CFR Regulation Number | 882.5330 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KLS MARTIN GMBH + CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KLS MARTIN GMBH And CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SYNTHES USA PRODUCTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |