510(k) K091686
K091686 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "LEFORTE NEUROSYSTEM BONE SCREW". The FDA issued a decision of Substantially Equivalent on Nov 13, 2009. 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
- Nov 13, 2009
- Date Received
- Jun 9, 2009
- 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)