LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Longevity It Highly Crosslinked Polyethylene Elevated Liners.

Pre-market Notification Details

• Device ID: K093846
• 510k Number: K093846
• Device Name: LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Benjamin Curson
• Correspondent: Benjamin Curson; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: LZO
• Subsequent Product Code: JDI
• Subsequent Product Code: LPH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-12-15
• Decision Date: 2010-02-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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