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510(k) K253894

BMD Titanium Spinal Fusion System by Global Biomedica s.r.o. — Product Code MAX

K253894 is an FDA 510(k) premarket notification submitted by Global Biomedica s.r.o. for the device "BMD Titanium Spinal Fusion System". The FDA issued a decision of Substantially Equivalent on May 28, 2026. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2026
Date Received
December 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
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  • K260385 — aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and tran (May 9, 2026)
  • K261067 — BEE PLIF Cage (April 30, 2026)
  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)

FDA data resources