FDA 510(k)

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System

Numéro K : K242350 · 2024-10-28

DemandeurSpinal Alignment Solutions, Inc.

Date de décision2024-10-28

Code produitNKB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Alignment Solutions, Inc.. It received FDA 510(k) clearance on 2024-10-28 under 510(k) number K242350. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Spinal Alignment Solutions Pelvic Incidence (PI) Rod System?

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is a medical device that received FDA 510(k) clearance on 2024-10-28. The listed applicant is Spinal Alignment Solutions, Inc.. The 510(k) number is K242350.

When did Spinal Alignment Solutions Pelvic Incidence (PI) Rod System receive FDA 510(k) clearance?

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System received FDA 510(k) clearance on 2024-10-28, under 510(k) number K242350.

Who is the listed applicant for Spinal Alignment Solutions Pelvic Incidence (PI) Rod System?

The FDA 510(k) record lists Spinal Alignment Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spinal Alignment Solutions Pelvic Incidence (PI) Rod System?

The FDA product code for Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is NKB.

Essais cliniques associés

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Dispositifs connexes (Code : NKB)

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Source officielle

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