Modification to Cranioplastic, Model 43-1280
FDA 510(k) K071791 · Codman & Shurtleff, Inc.
510(k) numberK071791
Submission
- Device name
- Modification to Cranioplastic, Model 43-1280
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- July 2, 2007
- Decision date
- July 30, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Modification to Cranioplastic, Model 43-1280 cleared by the FDA?
Modification to Cranioplastic, Model 43-1280 (K071791) received a 510(k) decision of Substantially Equivalent on July 30, 2007, 28 days after the submission was received.
What is the product code of K071791?
The FDA product code is GXP – Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.