PBJ
6 FDA 510(k) clearances · Product code
167 daysmedian time to decision
299 days90th percentile
6clearances measured
FDA profile
- Official device name
- Cranial Distraction System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5330
- Medical specialty
- Neurology
- Flags
- Implant · Life-sustaining
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CranioXpand (K230211) | KLS-Martin L.P. | 2023-11-21 |
| Craniomaxillofacial Distraction System (CMFD) (K170818) | Synthes USA Products, LLC | 2017-12-07 |
| Internal Distraction - Sterile (K163315) | KLS Martin L.P. | 2017-05-05 |
| RxG Distraction System (K150771) | KLS Martin L.P. | 2015-08-27 |
| OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR (K123885) | Osteomed LP | 2013-06-03 |
| OSTEOMED CRANIAL DISTRACTION SYSTEM (K121304) | Osteomed | 2012-08-22 |
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Every clearance here is in the API, with alerts when new ones post.