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FDA 510(k)

True Tulip, True M.I.S.

K-Number: K210816 · 2021-05-18

ApplicantInnovative Surgical Designs, Inc.
Decision Date2021-05-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

True Tulip, True M.I.S. is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical Designs, Inc.. It received FDA 510(k) clearance on 2021-05-18 under 510(k) number K210816. 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 True Tulip, True M.I.S.?

True Tulip, True M.I.S. is a medical device that received FDA 510(k) clearance on 2021-05-18. The listed applicant is Innovative Surgical Designs, Inc.. The 510(k) number is K210816.

When did True Tulip, True M.I.S. receive FDA 510(k) clearance?

True Tulip, True M.I.S. received FDA 510(k) clearance on 2021-05-18, under 510(k) number K210816.

Who is the listed applicant for True Tulip, True M.I.S.?

The FDA 510(k) record lists Innovative Surgical Designs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for True Tulip, True M.I.S.?

The FDA product code for True Tulip, True M.I.S. is NKB.

Other records listing Innovative Surgical Designs, Inc. 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.

K220297True Tulip, True M.I.S.K212627True Tulip, True M.I.S.K201780True Tulip System, True M.I.S. SystemK181584Redi-SpineK171559True Spinal Fixation SystemK170710True Spinal Fixation 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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