MASTERSL FEMORAL STEM

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 Mastersl Femoral Stem.

Pre-market Notification Details

• Device ID: K140975
• 510k Number: K140975
• Device Name: MASTERSL FEMORAL STEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: LIMACORPORATE S.P.A. 5010 LODGE POLE LANE Fort Wayne, IN 46814
• Contact: Stephen Peoples
• Correspondent: Stephen Peoples; LIMACORPORATE S.P.A. 5010 LODGE POLE LANE Fort Wayne, IN 46814
• Product Code: LZO
• Subsequent Product Code: JDI
• Subsequent Product Code: KWY
• Subsequent Product Code: KWZ
• Subsequent Product Code: LPH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-04-16
• Decision Date: 2014-06-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08033390269094	K140975	000
08033390298636	K140975	000
08033390298643	K140975	000
08033390298650	K140975	000
08033390298667	K140975	000
08033390298674	K140975	000
08033390298681	K140975	000
08033390298698	K140975	000
08033390298704	K140975	000
08033390298711	K140975	000
08033390024891	K140975	000
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08033390098311	K140975	000
08033390104203	K140975	000
08033390298629	K140975	000
08033390298612	K140975	000
08033390298605	K140975	000
08033390269117	K140975	000
08033390298483	K140975	000
08033390298490	K140975	000
08033390298506	K140975	000
08033390298513	K140975	000
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08033390298544	K140975	000
08033390298551	K140975	000
08033390298568	K140975	000
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08033390298582	K140975	000
08033390298599	K140975	000
08033390085304	K140975	000
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08033390197687	K140975	000
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08033390082990	K140975	000
08033390083003	K140975	000
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08033390083027	K140975	000
08033390083034	K140975	000
08033390083942	K140975	000
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08033390082914	K140975	000
08033390082921	K140975	000
08033390084543	K140975	000