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FDA 510(k)

ALTA Anterior Cervical Corpectomy System

K-Number: K190426 · 2019-10-24

ApplicantAstura Medical, LLC
Decision Date2019-10-24
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALTA Anterior Cervical Corpectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical, LLC. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K190426. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALTA Anterior Cervical Corpectomy System?

ALTA Anterior Cervical Corpectomy System is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Astura Medical, LLC. The 510(k) number is K190426.

When did ALTA Anterior Cervical Corpectomy System receive FDA 510(k) clearance?

ALTA Anterior Cervical Corpectomy System received FDA 510(k) clearance on 2019-10-24, under 510(k) number K190426.

Who is the listed applicant for ALTA Anterior Cervical Corpectomy System?

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

What is the FDA product code for ALTA Anterior Cervical Corpectomy System?

The FDA product code for ALTA Anterior Cervical Corpectomy System is PLR.

Other records listing Astura Medical, LLC 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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Related Devices (Code: PLR)

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.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLCK221542Galileo Vertebral Body Replacement DeviceBright SpineK212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K211320CAPRI Corpectomy Cage SystemK2m, 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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