510(k) K151104
K151104 is an FDA 510(k) premarket notification submitted by Spineart for the device "OTELO LL". The FDA issued a decision of Substantially Equivalent on January 6, 2016. The device falls under product code GAD (Retractor), a Class I device regulated under 21 CFR 878.4800. Spineart has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2016
- Date Received
- April 24, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retractor
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type