510(k) K113071
K113071 is an FDA 510(k) premarket notification submitted by Synthes for the device "SYNTHECEL DURA REPLACEMENT DEVICES". The FDA issued a decision of Substantially Equivalent on January 9, 2012. The device falls under product code GXQ (Dura Substitute), a Class II device regulated under 21 CFR 882.5910. Synthes has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2012
- Date Received
- October 17, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dura Substitute
- Device Class
- Class II
- Regulation Number
- 882.5910
- Review Panel
- NE
- Submission Type