J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030

Screw, Fixation, Intraosseous

JEIL MEDICAL CORPORATION

The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for J Tac Model Jt-md-035, Jt-md-040, Jt-md-045, Jt-cl-030.

Pre-market Notification Details

• Device ID: K101902
• 510k Number: K101902
• Device Name: J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
• Classification: Screw, Fixation, Intraosseous
• Applicant: JEIL MEDICAL CORPORATION 1733 CANTON LANE Marietta, GA 30062
• Contact: Cathy Cambria
• Correspondent: Cathy Cambria; JEIL MEDICAL CORPORATION 1733 CANTON LANE Marietta, GA 30062
• Product Code: DZL
• CFR Regulation Number: 872.4880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-08
• Decision Date: 2011-02-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809265159674	K101902	000
08809265159667	K101902	000
08809265159315	K101902	000
08809265159308	K101902	000
08806390822756	K101902	000
08806390822749	K101902	000