Osteomed Smartflex Cranial Spring Distractor
FDA 510(k) K123885 · Osteomed LP
510(k) numberK123885
Submission
- Device name
- Osteomed Smartflex Cranial Spring Distractor
- Applicant
- Osteomed LP
Addison, TX, US - Received
- December 18, 2012
- Decision date
- June 3, 2013
- 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 |
|---|---|---|---|
| K230211 | CranioXpandPBJ · Traditional | KLS-Martin L.P. | 11/21/2023SE |
| 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 |
| K121304 | Osteomed Cranial Distraction SystemPBJ · Traditional | Osteomed | 08/22/2012SE |
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Questions and answers
When was Osteomed Smartflex Cranial Spring Distractor cleared by the FDA?
Osteomed Smartflex Cranial Spring Distractor (K123885) received a 510(k) decision of Substantially Equivalent on June 3, 2013, 167 days after the submission was received.
What is the product code of K123885?
The FDA product code is PBJ – Cranial Distraction System, a Class II (moderate risk) device regulated under 21 CFR 882.5330.