BIPOLAR HIP DEVICE

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

ZIMMER

The following data is part of a premarket notification filed by Zimmer with the FDA for Bipolar Hip Device.

Pre-market Notification Details

• Device ID: K833991
• 510k Number: K833991
• Device Name: BIPOLAR HIP DEVICE
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
• Applicant: ZIMMER P.O. Box 708 Warsaw, IN 46580
• Contact: Max Sherman
• Correspondent: Max Sherman; ZIMMER, INC. P.O. Box 708 Warsaw, IN 46580
• Product Code: KWY
• CFR Regulation Number: 888.3390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-11-21
• Decision Date: 1984-01-30

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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