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FDA 510(k)

Tiger 2 System

K-Number: K253943 · 2026-07-24

ApplicantZavation Medical Products, LLC
Decision Date2026-07-24
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tiger 2 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 2026-07-24 under 510(k) number K253943. 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 Tiger 2 System?

Tiger 2 System is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K253943.

When did Tiger 2 System receive FDA 510(k) clearance?

Tiger 2 System received FDA 510(k) clearance on 2026-07-24, under 510(k) number K253943.

Who is the listed applicant for Tiger 2 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 Tiger 2 System?

The FDA product code for Tiger 2 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.

K243908Tiger 2 SystemK233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF SystemK231811Zavation Connector SystemK223808Zavation Navigation Instrument SystemK230731Zavation ALIF SystemK221726Uni-FuZe-C Bone Strip

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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.K261284Invictus® 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.K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)

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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