CranioXpand
FDA 510(k) K230211 · KLS-Martin L.P.
510(k) numberK230211
Submission
- Device name
- CranioXpand
- Applicant
- KLS-Martin L.P.
Jacksonville, FL, US - Received
- January 26, 2023
- Decision date
- November 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBJ – Cranial Distraction System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5330
- Specialty
- Neurology
- Implant
- Yes
- Life-sustaining
- Yes
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.
Other 510(k)s with product code PBJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170818 | Craniomaxillofacial Distraction System (CMFD)PBJ · Traditional | Synthes USA Products, LLC | 12/07/2017SE |
| K163315 | Internal Distraction - SterilePBJ · Traditional | KLS Martin L.P. | 05/05/2017SE |
| K150771 | RxG Distraction SystemPBJ · Traditional | KLS Martin L.P. | 08/27/2015SE |
| K123885 | Osteomed Smartflex Cranial Spring DistractorPBJ · Traditional | Osteomed LP | 06/03/2013SE |
| K121304 | Osteomed Cranial Distraction SystemPBJ · Traditional | Osteomed | 08/22/2012SE |
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Questions and answers
When was CranioXpand cleared by the FDA?
CranioXpand (K230211) received a 510(k) decision of Substantially Equivalent on November 21, 2023, 299 days after the submission was received.
What is the product code of K230211?
The FDA product code is PBJ – Cranial Distraction System, a Class II (moderate risk) device regulated under 21 CFR 882.5330.