NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS

Prosthesis, Partial Ossicular Replacement

HEINZ KURZ GMBH MEDIZINTECHNIK

The following data is part of a premarket notification filed by Heinz Kurz Gmbh Medizintechnik with the FDA for Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes Prosthesis.

Pre-market Notification Details

• Device ID: K130512
• 510k Number: K130512
• Device Name: NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
• Classification: Prosthesis, Partial Ossicular Replacement
• Applicant: HEINZ KURZ GMBH MEDIZINTECHNIK TUBINGER STRASSE 3 Dusslingen, DE D-72144
• Contact: Kristina Bitzer
• Correspondent: Kristina Bitzer; HEINZ KURZ GMBH MEDIZINTECHNIK TUBINGER STRASSE 3 Dusslingen, DE D-72144
• Product Code: ETB
• CFR Regulation Number: 874.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-02-27
• Decision Date: 2013-12-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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EHKM10060081	K130512	000
EHKM10060071	K130512	000
EHKM10060061	K130512	000
EHKM10060051	K130512	000
EHKM10060041	K130512	000
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EHKM10062911	K130512	000
EHKM10062901	K130512	000
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EHKM10062871	K130512	000
EHKM10060091	K130512	000
EHKM10060101	K130512	000
EHKM10060431	K130512	000
EHKM10060311	K130512	000
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EHKM10062651	K130512	000
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EHKM10062691	K130512	000
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EHKM10062801	K130512	000
EHKM10062791	K130512	000
EHKM10062781	K130512	000
EHKM10062771	K130512	000
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EHKM10072051	K130512	000
EHKM10072061	K130512	000
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EHKM10060581	K130512	000
EHKM10060591	K130512	000
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EHKM10060451	K130512	000