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FDA 510(k)

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System

K-Number: K252346 · 2025-10-21

ApplicantAstura Medical
Decision Date2025-10-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OLYMPIC Posterior Spinal Fixation System; MASADA Modular 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 2025-10-21 under 510(k) number K252346. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System?

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Astura Medical. The 510(k) number is K252346.

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

OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System received FDA 510(k) clearance on 2025-10-21, under 510(k) number K252346.

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

The FDA product code for OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System is NKB.

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 SystemK243259MASADA Modular Spinal Fixation SystemK240160EGPS Navigated InstrumentsK233359DOMINION Expandable Corpectomy SystemK231694MASADA Modular Spinal Fixation SystemK232211REUNION Sacroiliac Joint Fusion System

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Related Devices (Code: NKB)

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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