Cranial Distraction System
Regulation 882.5330
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PBJ
| Company | 510(k)s | Recalls |
|---|---|---|
| KLS Martin L.P. | 3 | 0 |
| Osteomed | 2 | 0 |
| Synthes USA Products, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 21, 2023 | K230211 | CranioXpand KLS-Martin L.P. | PBJ |
| Dec 7, 2017 | K170818 | Craniomaxillofacial Distraction System (CMFD) Synthes USA Products, LLC | PBJ |
| May 5, 2017 | K163315 | Internal Distraction - Sterile KLS Martin L.P. | PBJ |
| Aug 27, 2015 | K150771 | RxG Distraction System KLS Martin L.P. | PBJ |
| Jun 3, 2013 | K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR Osteomed LP | PBJ |
| Aug 22, 2012 | K121304 | OSTEOMED CRANIAL DISTRACTION SYSTEM Osteomed | PBJ |
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