OPTIMESH

Mesh, Surgical, Metal

SPINEOLOGY, INC.

The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Optimesh.

Pre-market Notification Details

• Device ID: K014200
• 510k Number: K014200
• Device Name: OPTIMESH
• Classification: Mesh, Surgical, Metal
• Applicant: SPINEOLOGY, INC. 1815 NORTHWESTERN AVE. Stillwater, MN 55082
• Contact: Pamela R Snyder
• Correspondent: Pamela R Snyder; SPINEOLOGY, INC. 1815 NORTHWESTERN AVE. Stillwater, MN 55082
• Product Code: EZX
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Se - With Limitations (SESU)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-12-21
• Decision Date: 2003-11-26
• Summary: summary