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FDA 510(k)

Fassier-Duval Telescoping IM System

K-Number: K241983 · 2025-02-21

ApplicantOrthopediatrics Canada Ulc Dba Pega Medical
Decision Date2025-02-21
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Fassier-Duval Telescoping IM System is the device name listed in this FDA 510(k) record. The listed applicant is Orthopediatrics Canada Ulc Dba Pega Medical. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K241983. 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 Fassier-Duval Telescoping IM System?

Fassier-Duval Telescoping IM System is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Orthopediatrics Canada Ulc Dba Pega Medical. The 510(k) number is K241983.

When did Fassier-Duval Telescoping IM System receive FDA 510(k) clearance?

Fassier-Duval Telescoping IM System received FDA 510(k) clearance on 2025-02-21, under 510(k) number K241983.

Who is the listed applicant for Fassier-Duval Telescoping IM System?

The FDA 510(k) record lists Orthopediatrics Canada Ulc Dba Pega Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fassier-Duval Telescoping IM System?

The FDA product code for Fassier-Duval Telescoping IM System is HSB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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