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FDA 510(k)

BMD Titanium Spinal Fusion System

K-Number: K253894 · 2026-05-28

ApplicantGlobal Biomedica s.r.o.
Decision Date2026-05-28
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BMD Titanium Spinal Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Global Biomedica s.r.o.. It received FDA 510(k) clearance on 2026-05-28 under 510(k) number K253894. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BMD Titanium Spinal Fusion System?

BMD Titanium Spinal Fusion System is a medical device that received FDA 510(k) clearance on 2026-05-28. The listed applicant is Global Biomedica s.r.o.. The 510(k) number is K253894.

When did BMD Titanium Spinal Fusion System receive FDA 510(k) clearance?

BMD Titanium Spinal Fusion System received FDA 510(k) clearance on 2026-05-28, under 510(k) number K253894.

Who is the listed applicant for BMD Titanium Spinal Fusion System?

The FDA 510(k) record lists Global Biomedica s.r.o. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BMD Titanium Spinal Fusion System?

The FDA product code for BMD Titanium Spinal Fusion System is MAX.

Related Devices (Code: MAX)

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.

K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

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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