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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 the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2023-12-15 under 510(k) 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. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K231447.

When did Double Internal Joint Stabilizer- Elbow receive FDA 510(k) clearance?

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

Who is the listed applicant for Double Internal Joint Stabilizer- Elbow?

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

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

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

Other records listing Skeletal Dynamics, Inc. as applicant

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Related Devices (Code: OZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223318Internal Joint Stabilizer - ElbowSkeletal Dynamics, Inc.

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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