Percusys® Plus Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Joimax GmbH

The following data is part of a premarket notification filed by Joimax Gmbh with the FDA for Percusys® Plus Pedicle Screw System.

Pre-market Notification Details

• Device ID: K192680
• 510k Number: K192680
• Device Name: Percusys® Plus Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Joimax GmbH Amalienbadstr. 41, RaumFabrik 61 Karlsruhe, DE 76227
• Contact: Gary Mocnik
• Correspondent: Gary Mocnik; Joimax GmbH Amalienbadstr. 41, RaumFabrik 61 Karlsruhe, DE 76227
• Product Code: NKB
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-26
• Decision Date: 2019-12-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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