OMEGA+ COMPRESSION SCREW SYSTEM

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Omega+ Compression Screw System.

Pre-market Notification Details

• Device ID: K955306
• 510k Number: K955306
• Device Name: OMEGA+ COMPRESSION SCREW SYSTEM
• Classification: Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
• Applicant: HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070
• Contact: Margaret F Crowe
• Correspondent: Margaret F Crowe; HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070
• Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-11-20
• Decision Date: 1996-04-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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