HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING

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 Harris/galante Porous (hgp) Hip Prosthesis With Calcicoat Ceramic Coating.

Pre-market Notification Details

• Device ID: K980711
• 510k Number: K980711
• Device Name: HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Ruth Ann Wood
• Correspondent: Ruth Ann Wood; 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: 1998-02-24
• Decision Date: 1998-11-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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