BIORETEC ACTIVASCREW INTERFERENCE

Fastener, Fixation, Biodegradable, Soft Tissue

BIORETEC LTD

The following data is part of a premarket notification filed by Bioretec Ltd with the FDA for Bioretec Activascrew Interference.

Pre-market Notification Details

• Device ID: K130716
• 510k Number: K130716
• Device Name: BIORETEC ACTIVASCREW INTERFERENCE
• Classification: Fastener, Fixation, Biodegradable, Soft Tissue
• Applicant: BIORETEC LTD HERMIANKATU 22 MODULIGHT BLDG Tampere, FI Fi-33720
• Contact: Mari Ruotsalainen
• Correspondent: Mari Ruotsalainen; BIORETEC LTD HERMIANKATU 22 MODULIGHT BLDG Tampere, FI Fi-33720
• Product Code: MAI
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-15
• Decision Date: 2013-08-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06438394007376	K130716	000
E30210100904159	K130716	000
E30210100904109	K130716	000
06438394007451	K130716	000
06438394007390	K130716	000
06438394007345	K130716	000
06438394007321	K130716	000
06438394007512	K130716	000
06438394007482	K130716	000
E30210100904209	K130716	000
E30210100905109	K130716	000
E30210100907269	K130716	000
E30210100907249	K130716	000
E30210100907209	K130716	000
E30210100906269	K130716	000
E30210100906209	K130716	000
E30210100906159	K130716	000
E30210100905209	K130716	000
E30210100905159	K130716	000
06438394007475	K130716	000
06438394007468	K130716	000
06438394007536	K130716	000
06438394007529	K130716	000
06438394007505	K130716	000
06438394007499	K130716	000
06438394007444	K130716	000
06438394007420	K130716	000
06438394007413	K130716	000
06438394007406	K130716	000
06438394007543	K130716	000
06438394007550	K130716	000
06438394007437	K130716	000
06438394007383	K130716	000
06438394007369	K130716	000
06438394009134	K130716	000
06438394009127	K130716	000
06438394007581	K130716	000
06438394007574	K130716	000
06438394007567	K130716	000
E30210100907309	K130716	000
E30210100908209	K130716	000
E30210100908249	K130716	000
E302BAI08289	K130716	000
E302BAI08249	K130716	000
E302BAI08209	K130716	000
E302BAI07309	K130716	000
E302BAI07269	K130716	000
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E302BAI07209	K130716	000
E302BAI06269	K130716	000
E302BAI08309	K130716	000
E302BAI08339	K130716	000
E302BAI10309	K130716	000
E302BAI10289	K130716	000
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E302BAI09339	K130716	000
E302BAI09309	K130716	000
E302BAI09289	K130716	000
E302BAI09249	K130716	000
E302BAI09209	K130716	000
E302BAI06209	K130716	000
E302BAI06159	K130716	000
E30210100909339	K130716	000
E30210100909309	K130716	000
E30210100909289	K130716	000
E30210100909249	K130716	000
E30210100909209	K130716	000
E30210100908339	K130716	000
E30210100908309	K130716	000
E30210100908289	K130716	000
E30210100910249	K130716	000
E30210100910289	K130716	000
E302BAI05209	K130716	000
E302BAI05159	K130716	000
E302BAI05109	K130716	000
E302BAI04209	K130716	000
E302BAI04159	K130716	000
E302BAI04109	K130716	000
E30210100910339	K130716	000
E30210100910309	K130716	000
E302BAI10339	K130716	000