Osteo-Mesh TM-300
FDA 510(k) K984230 · Osteogenics Biomedical, Inc.
510(k) numberK984230
Submission
- Device name
- Osteo-Mesh TM-300
- Applicant
- Osteogenics Biomedical, Inc.
Fort Worth, TX, US - Received
- November 25, 1998
- Decision date
- February 4, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Osteo-Mesh TM-300 cleared by the FDA?
Osteo-Mesh TM-300 (K984230) received a 510(k) decision of Substantially Equivalent on February 4, 1999, 71 days after the submission was received.
What is the product code of K984230?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.