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FDA 510(k)

OLYMPIC Deformity Band System

K-Number: K222097 · 2023-05-04

ApplicantAstura Medical
Decision Date2023-05-04
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OLYMPIC Deformity Band System is a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2023-05-04 under approval number K222097. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPIC Deformity Band System?

OLYMPIC Deformity Band System is a medical device that received FDA 510(k) clearance on 2023-05-04. It is manufactured by Astura Medical. The 510(k) number is K222097.

When was OLYMPIC Deformity Band System approved by the FDA?

OLYMPIC Deformity Band System received FDA 510(k) clearance on 2023-05-04, under approval number K222097.

What company makes OLYMPIC Deformity Band System?

OLYMPIC Deformity Band System is manufactured by Astura Medical.

What is the FDA product code for OLYMPIC Deformity Band System?

The FDA product code for OLYMPIC Deformity Band System is OWI.

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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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