OPTIMA, SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

U&I CORP., AMERICA

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

Pre-market Notification Details

• Device ID: K024096
• 510k Number: K024096
• Device Name: OPTIMA, SPINAL SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: U&I CORP., AMERICA 6132 SOUTH 380 WEST, Murray, UT 84107 -6988
• Contact: Patrick Moore
• Correspondent: Patrick Moore; U&I CORP., AMERICA 6132 SOUTH 380 WEST, Murray, UT 84107 -6988
• Product Code: MNI
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-12-12
• Decision Date: 2003-03-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800037559838	K024096	000
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