INTEGRA TOTAL WRIST FUSION SYSTEM

Plate, Fixation, Bone

INTEGRA LIFESCIENCES CORPORATION

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Total Wrist Fusion System.

Pre-market Notification Details

• Device ID: K093163
• 510k Number: K093163
• Device Name: INTEGRA TOTAL WRIST FUSION SYSTEM
• Classification: Plate, Fixation, Bone
• Applicant: INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536
• Contact: Stephen Beier
• Correspondent: Stephen Beier; INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. Plainsboro, NJ 08536
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-06
• Decision Date: 2009-12-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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