ROMEO® 2 Posterior Osteosynthesis System
K-Number: K172101 · 2017-09-26
ApplicantSpineart
Decision Date2017-09-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ROMEO® 2 Posterior Osteosynthesis System is a medical device manufactured by Spineart. It received FDA 510(k) clearance on 2017-09-26 under approval number K172101. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ROMEO® 2 Posterior Osteosynthesis System?
ROMEO® 2 Posterior Osteosynthesis System is a medical device that received FDA 510(k) clearance on 2017-09-26. It is manufactured by Spineart. The 510(k) number is K172101.
When was ROMEO® 2 Posterior Osteosynthesis System approved by the FDA?
ROMEO® 2 Posterior Osteosynthesis System received FDA 510(k) clearance on 2017-09-26, under approval number K172101.
What company makes ROMEO® 2 Posterior Osteosynthesis System?
ROMEO® 2 Posterior Osteosynthesis System is manufactured by Spineart.
What is the FDA product code for ROMEO® 2 Posterior Osteosynthesis System?
The FDA product code for ROMEO® 2 Posterior Osteosynthesis System is NKB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.