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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 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.

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. 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.

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.

NCT07062510The Effects of Balanced Seating Pressure on Pelvic Asymmetry: A Pilot StudyCOMPLETEDNCT07741162Paraspinal NMES and Spinopelvic Alignment After Knee ArthroplastyNOT_YET_RECRUITING

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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