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: K112108
• 510k Number: K112108
• Device Name: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215
• Contact: Frank P Ennesi
• Correspondent: Frank P Ennesi; 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: 2011-07-22
• Decision Date: 2011-08-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07640139349873	K112108	000
07640139348227	K112108	000
07640139348210	K112108	000
07640139348203	K112108	000
07640139348159	K112108	000
07640139348135	K112108	000
07640139348128	K112108	000
07640139348111	K112108	000
07640139348104	K112108	000
07640139348098	K112108	000
07640139348074	K112108	000
07640139348050	K112108	000
07640139348234	K112108	000
07640139349637	K112108	000
07640139349859	K112108	000
07640139349842	K112108	000
07640139349798	K112108	000
07640139349729	K112108	000
07640139349712	K112108	000
07640139349705	K112108	000
07640139349699	K112108	000
07640139349682	K112108	000
07640139349668	K112108	000
07640139349651	K112108	000
07640139349644	K112108	000
07640139348043	K112108	000