510(k) K213849
K213849 is an FDA 510(k) premarket notification submitted by Alphatec Spine, Inc. for the device "SafeOp 2: Neural Informatix System". The FDA issued a decision of Substantially Equivalent on March 9, 2022. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Alphatec Spine, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 2022
- Date Received
- December 10, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Electrical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1870
- Review Panel
- NE
- Submission Type