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510(k) K222473

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods by Medos-International Sarl — Product Code NKB

K222473 is an FDA 510(k) premarket notification submitted by Medos-International Sarl for the device "EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods". The FDA issued a decision of Substantially Equivalent on Oct 13, 2022. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 13, 2022
Date Received
Aug 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type
510(k)

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… (Jul 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (Jul 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (Jun 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (Jun 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources