FDA 510(k)

Medline ReNewal Reprocessed Stryker External Fixation Devices

Numéro K : K163028 · 2016-12-28

DemandeurSurgical Instrument Service and Savings, Inc.

Date de décision2016-12-28

Code produitJEC

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Medline ReNewal Reprocessed Stryker External Fixation Devices is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Instrument Service and Savings, Inc.. It received FDA 510(k) clearance on 2016-12-28 under 510(k) number K163028. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Medline ReNewal Reprocessed Stryker External Fixation Devices?

Medline ReNewal Reprocessed Stryker External Fixation Devices is a medical device that received FDA 510(k) clearance on 2016-12-28. The listed applicant is Surgical Instrument Service and Savings, Inc.. The 510(k) number is K163028.

When did Medline ReNewal Reprocessed Stryker External Fixation Devices receive FDA 510(k) clearance?

Medline ReNewal Reprocessed Stryker External Fixation Devices received FDA 510(k) clearance on 2016-12-28, under 510(k) number K163028.

Who is the listed applicant for Medline ReNewal Reprocessed Stryker External Fixation Devices?

The FDA 510(k) record lists Surgical Instrument Service and Savings, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline ReNewal Reprocessed Stryker External Fixation Devices?

The FDA product code for Medline ReNewal Reprocessed Stryker External Fixation Devices is JEC.

Essais cliniques associés

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Source officielle

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