← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

MJO — Prosthesis, Intervertebral Disc

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
OR
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
pma: 9
0
RECALL ENTRIES

Recent clearances

P250028Synergy Spine Solutions, Inc. · pma2026-07-06
P110009Highridge Medical, LLC · pma2026-03-23
P110002Highridge Medical, LLC · pma2026-03-23
P120024Highridge Medical, LLC · pma2026-01-29
P070001Centinel Spine, LLC · pma2026-01-15
P050010Centinel Spine, LLC · pma2025-09-02
P200022Nuvasive, Inc. · pma2025-06-05
P170036Spinal Kinetics, LLC · pma2024-08-19

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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