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FDA PRODUCT CODE · CLASS II

OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

DEVICE CLASS
Class II
REGULATION
21 CFR 888.3080
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
21
510(K)/PMA CLEARANCES
510k: 21
0
RECALL ENTRIES

Recent clearances

K261353Kyocera Medical Technologies, Inc. · 510k2026-07-15
K260810Tyber Medical, LLC · 510k2026-06-10
K254202Medacta International S.A. · 510k2026-05-05
K253401Globus Medical, Inc. · 510k2026-04-29
K253559Spinal Elements, Inc. · 510k2026-02-25
K251829Degen Medical · 510k2025-12-08
K251575Alphatec Spine · 510k2025-09-03
K250072Avalign Technologies, Inc. · 510k2025-07-10

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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