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FDA 510(k)

Double Internal Joint Stabilizer- Elbow

K-Number: K231447 · 2023-12-15

ApplicantSkeletal Dynamics, Inc.
Decision Date2023-12-15
Product CodeOZI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Double Internal Joint Stabilizer- Elbow is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2023-12-15 under approval number K231447. 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 Double Internal Joint Stabilizer- Elbow?

Double Internal Joint Stabilizer- Elbow is a medical device that received FDA 510(k) clearance on 2023-12-15. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K231447.

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

Double Internal Joint Stabilizer- Elbow received FDA 510(k) clearance on 2023-12-15, under approval number K231447.

What company makes Double Internal Joint Stabilizer- Elbow?

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

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

The FDA product code for Double 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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