510(k) K040212
K040212 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "TRIGEN INTERTAN". The FDA issued a decision of Substantially Equivalent on February 20, 2004. The device falls under product code JDS (Nail, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 2004
- Date Received
- January 30, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nail, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type