Romeo Posterior Osteosynthesis System
FDA 510(k) K093936 · Spineart
510(k) numberK093936
Submission
- Device name
- Romeo Posterior Osteosynthesis System
- Applicant
- Spineart
Geneva, CH - Received
- December 22, 2009
- Decision date
- March 11, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Romeo Posterior Osteosynthesis System cleared by the FDA?
Romeo Posterior Osteosynthesis System (K093936) received a 510(k) decision of Substantially Equivalent on March 11, 2010, 79 days after the submission was received.
What is the product code of K093936?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.