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FDA 510(k)

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods

K-Number: K222473 · 2022-10-13

ApplicantMedos-International Sarl
Decision Date2022-10-13
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods is a medical device manufactured by Medos-International Sarl. It received FDA 510(k) clearance on 2022-10-13 under approval number K222473. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods?

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods is a medical device that received FDA 510(k) clearance on 2022-10-13. It is manufactured by Medos-International Sarl. The 510(k) number is K222473.

When was EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods approved by the FDA?

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods received FDA 510(k) clearance on 2022-10-13, under approval number K222473.

What company makes EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods?

EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods is manufactured by Medos-International Sarl.

What is the FDA product code for EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods?

The FDA product code for EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods is NKB.

Related Clinical Trials

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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