FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 Foundation (fmp) Porous Coated Spiked Acetabular System.

Pre-market Notification Details

• Device ID: K072154
• 510k Number: K072154
• Device Name: FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, 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: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-08-03
• Decision Date: 2007-12-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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