U & I AMERICA SPINAL HOOK SYSTEM

Appliance, Fixation, Spinal Interlaminal

U&I CORP., AMERICA

The following data is part of a premarket notification filed by U&i Corp., America with the FDA for U & I America Spinal Hook System.

Pre-market Notification Details

• Device ID: K031595
• 510k Number: K031595
• Device Name: U & I AMERICA SPINAL HOOK SYSTEM
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: U&I CORP., AMERICA 6132 SOUTH 380 WEST, SUITE 200 Murray, UT 84107 -6988
• Contact: Patrick Moore
• Correspondent: Patrick Moore; U&I CORP., AMERICA 6132 SOUTH 380 WEST, SUITE 200 Murray, UT 84107 -6988
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-05-21
• Decision Date: 2003-06-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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