510(k) K101902

J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030 by Jeil Medical Corporation — Product Code DZL

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)

Source: FDA 510(k) database entry for K101902. Report a data issue: hello@regdatalab.com.