510(k) K043106
K043106 is an FDA 510(k) premarket notification submitted by Linvatec Corp. for the device "PINN-ACL CROSSPIN". The FDA issued a decision of Substantially Equivalent on January 19, 2005. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Linvatec Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2005
- Date Received
- November 9, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type