Codman Craniosorb Absorbable Fixation System Purple Rivets
FDA 510(k) K003549 · Codman & Shurtleff, Inc.
510(k) numberK003549
Submission
- Device name
- Codman Craniosorb Absorbable Fixation System Purple Rivets
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- November 17, 2000
- Decision date
- February 15, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Codman Craniosorb Absorbable Fixation System Purple Rivets cleared by the FDA?
Codman Craniosorb Absorbable Fixation System Purple Rivets (K003549) received a 510(k) decision of Substantially Equivalent on February 15, 2001, 90 days after the submission was received.
What is the product code of K003549?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.