510(k) K231787
K231787 is an FDA 510(k) premarket notification submitted by Science & Bio Materials (S.B.M.) Sas for the device "ecoFIX®". The FDA issued a decision of Substantially Equivalent on July 26, 2023. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Science & Bio Materials (S.B.M.) Sas has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2023
- Date Received
- June 20, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type