Pro-X1 Trochanteric Nailing System
K-Number: K221621 · 2023-03-06
ApplicantX-Bolt Orthopedics
Decision Date2023-03-06
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Pro-X1 Trochanteric Nailing System is a medical device manufactured by X-Bolt Orthopedics. It received FDA 510(k) clearance on 2023-03-06 under approval number K221621. 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 Pro-X1 Trochanteric Nailing System?
Pro-X1 Trochanteric Nailing System is a medical device that received FDA 510(k) clearance on 2023-03-06. It is manufactured by X-Bolt Orthopedics. The 510(k) number is K221621.
When was Pro-X1 Trochanteric Nailing System approved by the FDA?
Pro-X1 Trochanteric Nailing System received FDA 510(k) clearance on 2023-03-06, under approval number K221621.
What company makes Pro-X1 Trochanteric Nailing System?
Pro-X1 Trochanteric Nailing System is manufactured by X-Bolt Orthopedics.
What is the FDA product code for Pro-X1 Trochanteric Nailing System?
The FDA product code for Pro-X1 Trochanteric Nailing 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.