510(k) K120589
K120589 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "MILAGRO INTERFERENCE SCREWS". The FDA issued a decision of Substantially Equivalent on Apr 24, 2012. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 24, 2012
- Date Received
- Feb 28, 2012
- Clearance Type
- Traditional
- 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
- 510(k)