CONVERGE ACETABULAR SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

SULZER ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Sulzer Orthopedics, Inc. with the FDA for Converge Acetabular System.

Pre-market Notification Details

• Device ID: K012739
• 510k Number: K012739
• Device Name: CONVERGE ACETABULAR SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717
• Contact: Mitchell A Dhority
• Correspondent: Mitchell A Dhority; SULZER ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-08-16
• Decision Date: 2001-11-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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