KOBY SURGICAL INTERNAL FIXATION SYSTEM

Screw, Fixation, Bone

KOBY SURGICAL

The following data is part of a premarket notification filed by Koby Surgical with the FDA for Koby Surgical Internal Fixation System.

Pre-market Notification Details

• Device ID: K060026
• 510k Number: K060026
• Device Name: KOBY SURGICAL INTERNAL FIXATION SYSTEM
• Classification: Screw, Fixation, Bone
• Applicant: KOBY SURGICAL 16350 PARK TEN PL., SUITE 101 Houston, TX 77084
• Contact: Perry Forrester
• Correspondent: Perry Forrester; KOBY SURGICAL 16350 PARK TEN PL., SUITE 101 Houston, TX 77084
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-01-04
• Decision Date: 2006-01-26
• Summary: summary

NIH GUDID Devices

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