510(k) K953406
K953406 is an FDA 510(k) premarket notification submitted by Electro-Biology, Inc. for the device "EBI X FIX DYNAFIX SYSTEM (DFS)". The FDA issued a decision of Substantially Equivalent on October 31, 1995. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Electro-Biology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1995
- Date Received
- July 20, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type