Inion CompressOn Screw

Screw, Fixation, Bone

Inion Oy

The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Compresson Screw.

Pre-market Notification Details

• Device ID: K203105
• 510k Number: K203105
• Device Name: Inion CompressOn Screw
• 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: 2020-10-15
• Decision Date: 2021-01-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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