DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

LIMACORPORATE S.P.A.

The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for Delta Tt Cups, Delta Tt Liners, Bone Screws.

Pre-market Notification Details

• Device ID: K112898
• 510k Number: K112898
• Device Name: DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: LIMACORPORATE S.P.A. P.O. BOX 696 Winona Lake, IN 46590 -696
• Contact: Cheryl Hastings
• Correspondent: Cheryl Hastings; LIMACORPORATE S.P.A. P.O. BOX 696 Winona Lake, IN 46590 -696
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-03
• Decision Date: 2012-12-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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