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FDA 510(k)

UNiD™ Spine Analyzer

K-Number: K251629 · 2025-08-07

ApplicantMedicrea International S.A.S. (Medtronic)
Decision Date2025-08-07
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UNiD™ Spine Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Medicrea International S.A.S. (Medtronic). It received FDA 510(k) clearance on 2025-08-07 under 510(k) number K251629. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNiD™ Spine Analyzer?

UNiD™ Spine Analyzer is a medical device that received FDA 510(k) clearance on 2025-08-07. The listed applicant is Medicrea International S.A.S. (Medtronic). The 510(k) number is K251629.

When did UNiD™ Spine Analyzer receive FDA 510(k) clearance?

UNiD™ Spine Analyzer received FDA 510(k) clearance on 2025-08-07, under 510(k) number K251629.

Who is the listed applicant for UNiD™ Spine Analyzer?

The FDA 510(k) record lists Medicrea International S.A.S. (Medtronic) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNiD™ Spine Analyzer?

The FDA product code for UNiD™ Spine Analyzer is QIH.

Other records listing Medicrea International S.A.S. (Medtronic) 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.

K261289UNiD™ Spine Analyzer (SW3002)K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)K241164IB3D™ PL Spinal System

Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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