HARRIS-GALANTE POROUS TOTAL HIP SYS

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 Harris-galante Porous Total Hip Sys.

Pre-market Notification Details

• Device ID: K840643
• 510k Number: K840643
• Device Name: HARRIS-GALANTE POROUS TOTAL HIP SYS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: ZIMMER, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-02-15
• Decision Date: 1984-04-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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