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FDA 510(k)

EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)

K-Number: K220374 · 2022-03-08

ApplicantMedos International SARL
Decision Date2022-03-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2022-03-08 under 510(k) number K220374. 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 VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)?

EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) is a medical device that received FDA 510(k) clearance on 2022-03-08. The listed applicant is Medos International SARL. The 510(k) number is K220374.

When did EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) receive FDA 510(k) clearance?

EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) received FDA 510(k) clearance on 2022-03-08, under 510(k) number K220374.

Who is the listed applicant for EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)?

The FDA product code for EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) is NKB.

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Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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