MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS

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 Modulus Stems, Modulus Necks, Modular Femoral Heads, Cemented Cups, Lock Bipolar Heads.

Pre-market Notification Details

• Device ID: K112158
• 510k Number: K112158
• Device Name: MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS
• 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
• Subsequent Product Code: JDI
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-27
• Decision Date: 2012-05-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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