FOREX CORPORATION, OPTIMA, SPINAL SYSTEM

Orthosis, Spinal Pedicle Fixation

FOREX CORP.

The following data is part of a premarket notification filed by Forex Corp. with the FDA for Forex Corporation, Optima, Spinal System.

Pre-market Notification Details

• Device ID: K020279
• 510k Number: K020279
• Device Name: FOREX CORPORATION, OPTIMA, SPINAL SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: FOREX CORP. 6132 SOUTH 380 WEST, SUITE 200 Murray, UT 84107 -6988
• Contact: Robert Malone
• Correspondent: Robert Malone; FOREX CORP. 6132 SOUTH 380 WEST, SUITE 200 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: 2002-01-28
• Decision Date: 2002-06-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800015932202	K020279	000
08800037558213	K020279	000
08800037558206	K020279	000
08800037558190	K020279	000
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