Osteomed Cranial Flap Fixation System
FDA 510(k) K022277 · Osteomed Corp.
510(k) numberK022277
Submission
- Device name
- Osteomed Cranial Flap Fixation System
- Applicant
- Osteomed Corp.
Addison, TX, US - Received
- July 15, 2002
- Decision date
- April 1, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Osteomed Cranial Flap Fixation System cleared by the FDA?
Osteomed Cranial Flap Fixation System (K022277) received a 510(k) decision of Substantially Equivalent on April 1, 2003, 260 days after the submission was received.
What is the product code of K022277?
The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.