OSSIOfiber® Compression Staple
FDA 510(k) K241932 · OSSIO , Ltd.
510(k) numberK241932
Submission
- Device name
- OSSIOfiber® Compression Staple
- Applicant
- OSSIO , Ltd.
Caesarea, IL - Received
- July 1, 2024
- Decision date
- August 28, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNU – Staple, Absorbable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNU
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Questions and answers
When was OSSIOfiber® Compression Staple cleared by the FDA?
OSSIOfiber® Compression Staple (K241932) received a 510(k) decision of Substantially Equivalent on August 28, 2024, 58 days after the submission was received.
What is the product code of K241932?
The FDA product code is MNU – Staple, Absorbable, a Class II (moderate risk) device regulated under 21 CFR 888.3030.