510(k) K200933
K200933 is an FDA 510(k) premarket notification submitted by Syntec Scientific Corporation for the device "Syntec Non-Sterile Steinmann Pins System". The FDA issued a decision of Substantially Equivalent on May 5, 2020. The device falls under product code JDW (Pin, Fixation, Threaded), a Class II device regulated under 21 CFR 888.3040. Syntec Scientific Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2020
- Date Received
- April 7, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Threaded
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type