MIS Spine Frame Instrument Case

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

THOMPSON SURGICAL INSTRUMENTS

The following data is part of a premarket notification filed by Thompson Surgical Instruments with the FDA for Mis Spine Frame Instrument Case.

Pre-market Notification Details

• Device ID: K151347
• 510k Number: K151347
• Device Name: MIS Spine Frame Instrument Case
• Classification: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Applicant: THOMPSON SURGICAL INSTRUMENTS 10170 E CHERRY BEND RD Traverse City, MI 49684
• Contact: Stephanie Myers
• Correspondent: Stephanie Myers; THOMPSON SURGICAL INSTRUMENTS 10170 E CHERRY BEND RD Traverse City, MI 49684
• Product Code: KCT
• CFR Regulation Number: 880.6850 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-05-20
• Decision Date: 2015-10-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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