Osteomed Cranial Distraction System
FDA 510(k) K121304 · Osteomed
510(k) numberK121304
Submission
- Device name
- Osteomed Cranial Distraction System
- Applicant
- Osteomed
Addison, TX, US - Received
- May 1, 2012
- Decision date
- August 22, 2012
- 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 |
| K123885 | Osteomed Smartflex Cranial Spring DistractorPBJ · Traditional | Osteomed LP | 06/03/2013SE |
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| K162542 | OsteoMed PINNACLE DriverHBE · Traditional | 05/19/2017SE |
| K163303 | OsteoMed ExtremiFix Mid and Large Screw SystemHWC · Traditional | 04/04/2017SE |
| K162544 | OsteoMed PINNACLE DriverKMW · Traditional | 04/04/2017SE |
| K161041 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Special | 05/19/2016SE |
| K152145 | OsteoMed ExtremiLOCK Wrist Plating SystemHRS · Traditional | 12/21/2015SE |
Questions and answers
When was Osteomed Cranial Distraction System cleared by the FDA?
Osteomed Cranial Distraction System (K121304) received a 510(k) decision of Substantially Equivalent on August 22, 2012, 113 days after the submission was received.
What is the product code of K121304?
The FDA product code is PBJ – Cranial Distraction System, a Class II (moderate risk) device regulated under 21 CFR 882.5330.