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FDA 510(k)

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System

K-Number: K242350 · 2024-10-28

ApplicantSpinal Alignment Solutions, Inc.
Decision Date2024-10-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Spinal Alignment Solutions, Inc.. The 510(k) number is K242350.

When was Spinal Alignment Solutions Pelvic Incidence (PI) Rod System approved by the FDA?

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

What company makes Spinal Alignment Solutions Pelvic Incidence (PI) Rod System?

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is manufactured by Spinal Alignment Solutions, Inc..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 29212782 Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process. BMJ open (2017)

Related Devices (Code: NKB)

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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.

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