510(k) K984027
K984027 is an FDA 510(k) premarket notification submitted by Electro-Biology, Inc. for the device "EBI SPINELINK SYSTEM". The FDA issued a decision of Substantially Equivalent on January 19, 1999. The device falls under product code MNI (Orthosis, Spinal Pedicle Fixation), a Class II device regulated under 21 CFR 888.3070. Electro-Biology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 1999
- Date Received
- November 12, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Spinal Pedicle Fixation
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type