TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353

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

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trilogy Acetabular System Large Head Liner, Model 6353.

Pre-market Notification Details

• Device ID: K002960
• 510k Number: K002960
• Device Name: TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Karen Cain
• Correspondent: Karen Cain; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-09-22
• Decision Date: 2000-12-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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