Osteomed Low Profile Neuro Fixation System
FDA 510(k) K111176 · Osteomed LP
510(k) numberK111176
Submission
- Device name
- Osteomed Low Profile Neuro Fixation System
- Applicant
- Osteomed LP
Addison, TX, US - Received
- April 27, 2011
- Decision date
- August 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 Low Profile Neuro Fixation System cleared by the FDA?
Osteomed Low Profile Neuro Fixation System (K111176) received a 510(k) decision of Substantially Equivalent on August 15, 2011, 110 days after the submission was received.
What is the product code of K111176?
The FDA product code is GWO – Plate, Cranioplasty, Preformed, Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5320.