510(k) K101902
K101902 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030". The FDA issued a decision of Substantially Equivalent on Feb 8, 2011. The device falls under product code DZL (Screw, Fixation, Intraosseous), a Class II device regulated under 21 CFR 872.4880. Jeil Medical Corporation has 52 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 8, 2011
- Date Received
- Jul 8, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Screw, Fixation, Intraosseous
- Device Class
- Class II
- Regulation Number
- 872.4880
- Review Panel
- DE
- Submission Type
- 510(k)