The Progen Trochanteric Nail System
K-Number: K211086 · 2021-12-21
ApplicantOrtho Development Corporation
Decision Date2021-12-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
The Progen Trochanteric Nail System is a medical device manufactured by Ortho Development Corporation. It received FDA 510(k) clearance on 2021-12-21 under approval number K211086. 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 The Progen Trochanteric Nail System?
The Progen Trochanteric Nail System is a medical device that received FDA 510(k) clearance on 2021-12-21. It is manufactured by Ortho Development Corporation. The 510(k) number is K211086.
When was The Progen Trochanteric Nail System approved by the FDA?
The Progen Trochanteric Nail System received FDA 510(k) clearance on 2021-12-21, under approval number K211086.
What company makes The Progen Trochanteric Nail System?
The Progen Trochanteric Nail System is manufactured by Ortho Development Corporation.
What is the FDA product code for The Progen Trochanteric Nail System?
The FDA product code for The Progen Trochanteric 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.