Fitmore® Hip Stem

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

Zimmer GmbH

The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Fitmore® Hip Stem.

Pre-market Notification Details

• Device ID: K170072
• 510k Number: K170072
• Device Name: Fitmore® Hip Stem
• Classification: Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
• Applicant: Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404
• Contact: Thomas Lincoln
• Correspondent: Thomas Lincoln; Zimmer GmbH Sulzerallee 8 Winterthur, CH 8404
• Product Code: KWY
• Subsequent Product Code: JDI
• Subsequent Product Code: KWL
• Subsequent Product Code: KWZ
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3390 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-01-09
• Decision Date: 2017-02-07
• Summary: summary