IDEAL

Rod, Fixation, Intramedullary And Accessories

JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT

The following data is part of a premarket notification filed by Jiangsu Ideal Medical Science & Technology Co., Lt with the FDA for Ideal.

Pre-market Notification Details

• Device ID: K132428
• 510k Number: K132428
• Device Name: IDEAL
• Classification: Rod, Fixation, Intramedullary And Accessories
• Applicant: JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT 503 ROOM, 8 BLDG, 600 LIU ZHOU ROAD Shanghai, CN 200233
• Contact: Gong Bo
• Correspondent: Gong Bo; JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT 503 ROOM, 8 BLDG, 600 LIU ZHOU ROAD Shanghai, CN 200233
• Product Code: HSB
• CFR Regulation Number: 888.3020 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-08-05
• Decision Date: 2013-12-20
• Summary: summary