ESPIN

Arthroscope

NLT SPINE LTD

The following data is part of a premarket notification filed by Nlt Spine Ltd with the FDA for Espin.

Pre-market Notification Details

• Device ID: K120553
• 510k Number: K120553
• Device Name: ESPIN
• Classification: Arthroscope
• Applicant: NLT SPINE LTD 555 THIRTEENTH STREET NW Washington, DC 20004
• Contact: John J Smith
• Correspondent: John J Smith; NLT SPINE LTD 555 THIRTEENTH STREET NW Washington, DC 20004
• Product Code: HRX
• CFR Regulation Number: 888.1100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-02-23
• Decision Date: 2012-08-09
• Summary: summary