H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

LIMACORPORATE S.P.A.

The following data is part of a premarket notification filed by Limacorporate S.p.a. with the FDA for H-max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads.

Pre-market Notification Details

• Device ID: K112091
• 510k Number: K112091
• Device Name: H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• 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: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-21
• Decision Date: 2012-11-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08033390114790	K112091	000
08033390032094	K112091	000
08033390062824	K112091	000