SPINEMED

Equipment, Traction, Powered

CERT HEALTH SCIENCES, LLC

The following data is part of a premarket notification filed by Cert Health Sciences, Llc with the FDA for Spinemed.

Pre-market Notification Details

• Device ID: K030060
• 510k Number: K030060
• Device Name: SPINEMED
• Classification: Equipment, Traction, Powered
• Applicant: CERT HEALTH SCIENCES, LLC 203 MAIN ST. PMB 166 Flemington, NJ 08822
• Contact: Lynette Howard
• Product Code: ITH
• CFR Regulation Number: 890.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2003-01-07
• Decision Date: 2003-02-05
• Summary: summary