Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MSFX MIKRON SPINAL FIXATION SYSTEM

K-Number: K241657 · 2024-09-30

ApplicantMikron Makina Sanayi VE Ticaret Ltd. Sti.
Decision Date2024-09-30
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MSFX MIKRON SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mikron Makina Sanayi VE Ticaret Ltd. Sti.. It received FDA 510(k) clearance on 2024-09-30 under 510(k) number K241657. 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 MSFX MIKRON SPINAL FIXATION SYSTEM?

MSFX MIKRON SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2024-09-30. The listed applicant is Mikron Makina Sanayi VE Ticaret Ltd. Sti.. The 510(k) number is K241657.

When did MSFX MIKRON SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

MSFX MIKRON SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2024-09-30, under 510(k) number K241657.

Who is the listed applicant for MSFX MIKRON SPINAL FIXATION SYSTEM?

The FDA 510(k) record lists Mikron Makina Sanayi VE Ticaret Ltd. Sti. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MSFX MIKRON SPINAL FIXATION SYSTEM?

The FDA product code for MSFX MIKRON SPINAL FIXATION SYSTEM is NKB.

Other records listing Mikron Makina Sanayi VE Ticaret Ltd. Sti. 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.

K240484MSFX Mikron Cervical Anterior Plate System

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.

↑