510(k) K101971
K101971 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corp. for the device "SYNTEC OS SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 25, 2011. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Syntec Scientific Corp. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 25, 2011
- Date Received
- Jul 13, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Thoracolumbosacral Pedicle Screw System
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.