FDA Product Code
FDA Product Code PBJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5330
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230211 | CranioXpand | KLS-Martin L.P. | 2023-11-21 | Traditional | PDF ↗ |
| K170818 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017-12-07 | Traditional | PDF ↗ |
| K163315 | Internal Distraction - Sterile | KLS Martin L.P. | 2017-05-05 | Traditional | PDF ↗ |
| K150771 | RxG Distraction System | KLS Martin L.P. | 2015-08-27 | Traditional | PDF ↗ |
| K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | Osteomed LP | 2013-06-03 | Traditional | PDF ↗ |
| K121304 | OSTEOMED CRANIAL DISTRACTION SYSTEM | Osteomed | 2012-08-22 | Traditional | PDF ↗ |
Product code PBJ · Class II · Neurology. Data: openFDA.