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FDA 510(k)

SAS MIS Pelvic Incidence Rods

K-Number: K263172 · 2026-09-30

ApplicantSpinal Alignment Solutions, Inc.
Decision Date2026-09-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SAS MIS Pelvic Incidence Rods 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 2026-09-30 under 510(k) number K263172. 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 SAS MIS Pelvic Incidence Rods?

SAS MIS Pelvic Incidence Rods is a medical device that received FDA 510(k) clearance on 2026-09-30. The listed applicant is Spinal Alignment Solutions, Inc.. The 510(k) number is K263172.

When did SAS MIS Pelvic Incidence Rods receive FDA 510(k) clearance?

SAS MIS Pelvic Incidence Rods received FDA 510(k) clearance on 2026-09-30, under 510(k) number K263172.

Who is the listed applicant for SAS MIS Pelvic Incidence Rods?

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 SAS MIS Pelvic Incidence Rods?

The FDA product code for SAS MIS Pelvic Incidence Rods is NKB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Spinal Alignment Solutions, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod System

Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.K263062NOVIX Pedicle Screw SystemTdm Co., Ltd.K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLCK252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi

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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