Craniofix and CRANIOFIX2 Titanium Clamp System
FDA 510(k) K040864 · Aesculap
510(k) numberK040864
Submission
- Device name
- Craniofix and CRANIOFIX2 Titanium Clamp System
- Applicant
- Aesculap
Center Valley, PA, US - Received
- April 2, 2004
- Decision date
- June 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Craniofix and CRANIOFIX2 Titanium Clamp System cleared by the FDA?
Craniofix and CRANIOFIX2 Titanium Clamp System (K040864) received a 510(k) decision of Substantially Equivalent on June 17, 2004, 76 days after the submission was received.
What is the product code of K040864?
The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.