510(k) K092889
K092889 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corp. for the device "SYNTEC OSTEO-PLATE AND SCREW FIXATION". The FDA issued a decision of Substantially Equivalent on Jun 25, 2010. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Syntec Scientific Corp. has 12 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 25, 2010
- Date Received
- Sep 21, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Plate, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)