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FDA 510(k)

STRETTO™ Cable System

K-Number: K231333 · 2023-08-04

ApplicantGlobus Medical, Inc.
Decision Date2023-08-04
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRETTO™ Cable System is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K231333. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRETTO™ Cable System?

STRETTO™ Cable System is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Globus Medical, Inc.. The 510(k) number is K231333.

When did STRETTO™ Cable System receive FDA 510(k) clearance?

STRETTO™ Cable System received FDA 510(k) clearance on 2023-08-04, under 510(k) number K231333.

Who is the listed applicant for STRETTO™ Cable System?

The FDA 510(k) record lists Globus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRETTO™ Cable System?

The FDA product code for STRETTO™ Cable System is JDQ.

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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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