ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923

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 Zmr Hip System-xl, Models 9921, 9922 And 9923.

Pre-market Notification Details

• Device ID: K031572
• 510k Number: K031572
• Device Name: ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• 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: LPH
• Subsequent Product Code: LWJ
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-05-20
• Decision Date: 2003-06-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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