510(k) K964458
K964458 is an FDA 510(k) premarket notification submitted by Link America, Inc. for the device "ELLIS EXTERNAL MINI-FIXATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 9, 1996. 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. Link America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 1996
- Date Received
- November 7, 1996
- 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