510(k) K123885
- Device
- OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
- Applicant
- OSTEOMED LP
- 510(k) number
- K123885
- Product code
- PBJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-06-03
- Date received
- 2012-12-18
- Regulation
- 882.5330
- Classification name
- Cranial Distraction System
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PIEDAD PENA
- Address
- 3885 Arapaho Rd. Addison TX US 75001 75001
FDA Registration Numbers#
- 3009417901
- 3008868758
- 1057946
- 3008812560
- 2027754
- 9610905
- 3015212339
- 3006017180
- 1649518
Source Documents#
Other 510(k) Records For Product Code PBJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230211 | CranioXpand | KLS-Martin L.P. | 2023-11-21 |
| K170818 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | 2017-12-07 |
| K163315 | Internal Distraction - Sterile | KLS Martin L.P. | 2017-05-05 |
| K150771 | RxG Distraction System | KLS Martin L.P. | 2015-08-27 |
| K121304 | OSTEOMED CRANIAL DISTRACTION SYSTEM | Osteomed | 2012-08-22 |
Legacy Summary#
summary
FDA Review#
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