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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 the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2023-05-04 under 510(k) 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. The listed applicant is Astura Medical. The 510(k) number is K222097.

When did OLYMPIC Deformity Band System receive FDA 510(k) clearance?

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

Who is the listed applicant for OLYMPIC Deformity Band System?

The FDA 510(k) record lists Astura Medical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Astura Medical 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: OWI)

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.

K261374LigaPASS™ SystemMedicrea International S.A.SK253615Invictus Bands SystemAlphatec Spine, Inc.K230565HILINE™ Fixation SystemGlobus Medical, Inc.K213659LigaPASS™ 2.0 Ligament Augmentation SystemMedicrea International SAK211057LigaPASS® Spinal System, CD Horizon™ Spinal SystemMedtronic, Inc.K201240Mariner Cap SystemSeaSpine Orthopedics Corporation

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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