BIOFLEX

Posterior Metal/polymer Spinal System, Fusion

BIOSPINE CO., LTD.

The following data is part of a premarket notification filed by Biospine Co., Ltd. with the FDA for Bioflex.

Pre-market Notification Details

• Device ID: K072321
• 510k Number: K072321
• Device Name: BIOFLEX
• Classification: Posterior Metal/polymer Spinal System, Fusion
• Applicant: BIOSPINE CO., LTD. 1331 H STREET NW, 12TH FLOOR Washington, DC 20005
• Contact: Justin Eggleton
• Correspondent: Justin Eggleton; BIOSPINE CO., LTD. 1331 H STREET NW, 12TH FLOOR Washington, DC 20005
• Product Code: NQP
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-20
• Decision Date: 2008-03-25
• Summary: summary