Dyna Locking Trochanteric Nail™

FDA 510(k) K221084 · Innosys

Substantially Equivalent

510(k) numberK221084

Submission

Device name
Dyna Locking Trochanteric Nail™
Applicant
Innosys
Uijeongbu-Si, KR
Received
April 13, 2022
Decision date
March 3, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HSB – Rod, Fixation, Intramedullary And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3020
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Dyna Locking Trochanteric Nail™ cleared by the FDA?

Dyna Locking Trochanteric Nail™ (K221084) received a 510(k) decision of Substantially Equivalent on March 3, 2023, 324 days after the submission was received.

What is the product code of K221084?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.