Atlas Humeral Nail System
K-Number: K241484 · 2024-11-05
Decision Date2024-11-05
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Atlas Humeral Nail System is a medical device manufactured by Orthopedic Designs North America, Inc. (Odi-Na). It received FDA 510(k) clearance on 2024-11-05 under approval number K241484. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Atlas Humeral Nail System?
Atlas Humeral Nail System is a medical device that received FDA 510(k) clearance on 2024-11-05. It is manufactured by Orthopedic Designs North America, Inc. (Odi-Na). The 510(k) number is K241484.
When was Atlas Humeral Nail System approved by the FDA?
Atlas Humeral Nail System received FDA 510(k) clearance on 2024-11-05, under approval number K241484.
What company makes Atlas Humeral Nail System?
Atlas Humeral Nail System is manufactured by Orthopedic Designs North America, Inc. (Odi-Na).
What is the FDA product code for Atlas Humeral Nail System?
The FDA product code for Atlas Humeral Nail System is HSB.
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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.