ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

Orthosis, Spinal Pedicle Fixation

SPINEART

The following data is part of a premarket notification filed by Spineart with the FDA for Romeo Posterior Osteosynthesis System.

Pre-market Notification Details

• Device ID: K093936
• 510k Number: K093936
• Device Name: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215
• Contact: Franck Pennesi
• Correspondent: Franck Pennesi; SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215
• Product Code: MNI
• Subsequent Product Code: KWP
• Subsequent Product Code: MNH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-12-22
• Decision Date: 2010-03-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07640139344557	K093936	000
07640139344700	K093936	000
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