ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zca All-poly Acetabular Cup, Snap-in, Model 8005-946/958-32.

Pre-market Notification Details

• Device ID: K030153
• 510k Number: K030153
• Device Name: ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• 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: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-01-16
• Decision Date: 2003-04-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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