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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 the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2023-05-10 under 510(k) 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. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K223318.

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

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

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

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

Other records listing Skeletal Dynamics, Inc. as applicant

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.

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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.

K231447Double Internal 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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