X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER

Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented

ENCORE MEDICAL, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for X-alt Highly Cross Linked Ve Acetabular Liner.

Pre-market Notification Details

• Device ID: K130365
• 510k Number: K130365
• Device Name: X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
• Classification: Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, Porous, Uncemented
• Applicant: ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758
• Contact: Teffany Hutto
• Correspondent: Teffany Hutto; ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758
• Product Code: OQG
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-13
• Decision Date: 2013-09-23
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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