510(k) K023365
K023365 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "LEFORTE SYSTEM BONE SCREW". The FDA issued a decision of Substantially Equivalent on Apr 18, 2003. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Jeil Medical Corporation has 52 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 18, 2003
- Date Received
- Oct 7, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Screw, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)