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FDA 510(k)

Momentum® MIS Posterior Spinal Fixation System

K-Number: K223274 · 2022-11-28

ApplicantUlrich Medical USA
Decision Date2022-11-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Momentum® MIS Posterior Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich Medical USA. It received FDA 510(k) clearance on 2022-11-28 under 510(k) number K223274. 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 Momentum® MIS Posterior Spinal Fixation System?

Momentum® MIS Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-11-28. The listed applicant is Ulrich Medical USA. The 510(k) number is K223274.

When did Momentum® MIS Posterior Spinal Fixation System receive FDA 510(k) clearance?

Momentum® MIS Posterior Spinal Fixation System received FDA 510(k) clearance on 2022-11-28, under 510(k) number K223274.

Who is the listed applicant for Momentum® MIS Posterior Spinal Fixation System?

The FDA 510(k) record lists Ulrich Medical USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Momentum® MIS Posterior Spinal Fixation System?

The FDA product code for Momentum® MIS Posterior Spinal Fixation 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.

NCT03118505A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal ConditionsACTIVE_NOT_RECRUITING

Other records listing Ulrich Medical USA 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.

K252087Navigation Module of the Cortium® SystemK251719Momentum® Posterior Spinal Fixation SystemK241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyK240515uNion® MAX Cervical Plate SystemK231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone CementK230614Cortium™

View all 11 devices →

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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