VERTESSA

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

CALDERA MEDICAL, INC.

The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Vertessa.

Pre-market Notification Details

• Device ID: K120327
• 510k Number: K120327
• Device Name: VERTESSA
• Classification: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
• Applicant: CALDERA MEDICAL, INC. 5171 CLARETON DRIVE Agoura Hills, CA 91301
• Contact: Vicki Gail
• Correspondent: Vicki Gail; CALDERA MEDICAL, INC. 5171 CLARETON DRIVE Agoura Hills, CA 91301
• Product Code: OTO
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-02-02
• Decision Date: 2012-05-10
• Summary: summary