TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019

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 Taperfill Femoral Hip Stem 425-31-005_017 425-41-005_019.

Pre-market Notification Details

• Device ID: K130099
• 510k Number: K130099
• Device Name: TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758
• Contact: William Garzon
• Correspondent: William Garzon; ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758
• Product Code: LPH
• Subsequent Product Code: KWZ
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-01-15
• Decision Date: 2013-06-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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