INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)

Screw, Fixation, Bone

INION OY

The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Freedomscrew (alternative Marketing Name: Inion Otps Freedomscrew).

Pre-market Notification Details

• Device ID: K123672
• 510k Number: K123672
• Device Name: INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
• Classification: Screw, Fixation, Bone
• Applicant: INION OY LAAKARINKATU 2 Tampere, FI 33520
• Contact: Kati Marttinen
• Correspondent: Kati Marttinen; INION OY LAAKARINKATU 2 Tampere, FI 33520
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-11-29
• Decision Date: 2013-02-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06438408003714	K123672	000
06438408003547	K123672	000
06438408003530	K123672	000
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M224OSB35309P0	K123672	000
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M224OSC35459	K123672	000
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M224OSB35259	K123672	000
M224OSB35209	K123672	000
M224OSA45909	K123672	000
M224OSA45559	K123672	000
M224OSA45509	K123672	000
M224OSA45459	K123672	000
M224OSA45409	K123672	000
M224OSA45359	K123672	000
M224OSA35459	K123672	000
M224OSA35409	K123672	000
M224OSA35359	K123672	000
M224OSA35309	K123672	000
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