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FDA 510(k)

Internal Joint Stabilizer - Elbow

K-Number: K223318 · 2023-05-10

ApplicantSkeletal Dynamics, Inc.
Decision Date2023-05-10
Product CodeOZI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Internal Joint Stabilizer - Elbow is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2023-05-10 under approval number K223318. The device is classified under product code OZI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Internal Joint Stabilizer - Elbow?

Internal Joint Stabilizer - Elbow is a medical device that received FDA 510(k) clearance on 2023-05-10. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K223318.

When was Internal Joint Stabilizer - Elbow approved by the FDA?

Internal Joint Stabilizer - Elbow received FDA 510(k) clearance on 2023-05-10, under approval number K223318.

What company makes Internal Joint Stabilizer - Elbow?

Internal Joint Stabilizer - Elbow is manufactured by Skeletal Dynamics, Inc..

What is the FDA product code for Internal Joint Stabilizer - Elbow?

The FDA product code for Internal Joint Stabilizer - Elbow is OZI.

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Related Devices (Code: OZI)

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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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