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FDA 510(k)

Zavation Spinal System

K-Number: K190361 · 2019-03-18

ApplicantZavation Medical Products, LLC
Decision Date2019-03-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zavation Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2019-03-18 under 510(k) number K190361. 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 Zavation Spinal System?

Zavation Spinal System is a medical device that received FDA 510(k) clearance on 2019-03-18. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K190361.

When did Zavation Spinal System receive FDA 510(k) clearance?

Zavation Spinal System received FDA 510(k) clearance on 2019-03-18, under 510(k) number K190361.

Who is the listed applicant for Zavation Spinal System?

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

What is the FDA product code for Zavation Spinal System?

The FDA product code for Zavation Spinal System is NKB.

Other records listing Zavation Medical Products, 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.

K253943Tiger 2 SystemK243908Tiger 2 SystemK233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF SystemK231811Zavation Connector SystemK223808Zavation Navigation Instrument SystemK230731Zavation ALIF 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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