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FDA 510(k)

OLYMPIC Posterior Spinal Fixation System

K-Number: K153446 · 2016-04-08

ApplicantAstura Medical
Decision Date2016-04-08
Product CodeOSH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OLYMPIC Posterior Spinal Fixation 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 2016-04-08 under 510(k) number K153446. The device is classified under product code OSH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPIC Posterior Spinal Fixation System?

OLYMPIC Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Astura Medical. The 510(k) number is K153446.

When did OLYMPIC Posterior Spinal Fixation System receive FDA 510(k) clearance?

OLYMPIC Posterior Spinal Fixation System received FDA 510(k) clearance on 2016-04-08, under 510(k) number K153446.

Who is the listed applicant for OLYMPIC Posterior Spinal Fixation 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 Posterior Spinal Fixation System?

The FDA product code for OLYMPIC Posterior Spinal Fixation System is OSH.

Related Clinical Trials

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.

NCT03118505A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal ConditionsACTIVE_NOT_RECRUITING

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.

K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemK252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemK243259MASADA Modular Spinal Fixation SystemK240160EGPS Navigated InstrumentsK233359DOMINION Expandable Corpectomy SystemK231694MASADA Modular Spinal Fixation System

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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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