Codman Craniosorb Absorbable Fixation System Drill Bits
FDA 510(k) K002798 · Codman & Shurtleff, Inc.
510(k) numberK002798
Submission
- Device name
- Codman Craniosorb Absorbable Fixation System Drill Bits
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- September 7, 2000
- Decision date
- December 6, 2000
- 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 Drill Bits cleared by the FDA?
Codman Craniosorb Absorbable Fixation System Drill Bits (K002798) received a 510(k) decision of Substantially Equivalent on December 6, 2000, 90 days after the submission was received.
What is the product code of K002798?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.