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FDA 510(k)

Sweden & Martina Surgical Tray (Model ZSHORTY-INT)

K-Number: K182084 · 2020-11-04

ApplicantSweden & Martina S.P.A.
Decision Date2020-11-04
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is a medical device manufactured by Sweden & Martina S.P.A.. It received FDA 510(k) clearance on 2020-11-04 under approval number K182084. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sweden & Martina Surgical Tray (Model ZSHORTY-INT)?

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is a medical device that received FDA 510(k) clearance on 2020-11-04. It is manufactured by Sweden & Martina S.P.A.. The 510(k) number is K182084.

When was Sweden & Martina Surgical Tray (Model ZSHORTY-INT) approved by the FDA?

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) received FDA 510(k) clearance on 2020-11-04, under approval number K182084.

What company makes Sweden & Martina Surgical Tray (Model ZSHORTY-INT)?

Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is manufactured by Sweden & Martina S.P.A..

What is the FDA product code for Sweden & Martina Surgical Tray (Model ZSHORTY-INT)?

The FDA product code for Sweden & Martina Surgical Tray (Model ZSHORTY-INT) is KCT.

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Other Devices by Sweden & Martina S.P.A.

K162004PREMIUM Implant Systems SHELTA Implant Systems K172560PREMIUM ONE Implant Systems K162028PREMIUM - SHELTA Prosthetic Components K161989PREMIUM Implant Systems SHELTA Implant Systems K180365PRAMA White Implant Systems K222640Sweden & Martina Surgical Trays

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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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