Alliance Spine Raas Cranial Plating System
FDA 510(k) K141123 · Alliance Partners, LLC
510(k) numberK141123
Submission
- Device name
- Alliance Spine Raas Cranial Plating System
- Applicant
- Alliance Partners, LLC
Shelton, CT, US - Received
- May 1, 2014
- Decision date
- February 27, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Alliance Spine Raas Cranial Plating System cleared by the FDA?
Alliance Spine Raas Cranial Plating System (K141123) received a 510(k) decision of Substantially Equivalent on February 27, 2015, 302 days after the submission was received.
What is the product code of K141123?
The FDA product code is GWO – Plate, Cranioplasty, Preformed, Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5320.