Osteomed M3 System (SBF System)
FDA 510(k) K924138 · Osteomed Corp.
510(k) numberK924138
Submission
- Device name
- Osteomed M3 System (SBF System)
- Applicant
- Osteomed Corp.
Glendale, CA, US - Received
- August 18, 1992
- Decision date
- February 17, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Osteomed M3 System (SBF System) cleared by the FDA?
Osteomed M3 System (SBF System) (K924138) received a 510(k) decision of Substantially Equivalent on February 17, 1993, 183 days after the submission was received.
What is the product code of K924138?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.