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FDA 510(k)

Mercury® Spinal System, Overwatch® Spinal System

K-Number: K191576 · 2019-09-16

ApplicantSpinal Elements, Inc.
Decision Date2019-09-16
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mercury® Spinal System, Overwatch® Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2019-09-16 under 510(k) number K191576. 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 Mercury® Spinal System, Overwatch® Spinal System?

Mercury® Spinal System, Overwatch® Spinal System is a medical device that received FDA 510(k) clearance on 2019-09-16. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K191576.

When did Mercury® Spinal System, Overwatch® Spinal System receive FDA 510(k) clearance?

Mercury® Spinal System, Overwatch® Spinal System received FDA 510(k) clearance on 2019-09-16, under 510(k) number K191576.

Who is the listed applicant for Mercury® Spinal System, Overwatch® Spinal System?

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

What is the FDA product code for Mercury® Spinal System, Overwatch® Spinal System?

The FDA product code for Mercury® Spinal System, Overwatch® Spinal System is NKB.

Other records listing Spinal Elements, Inc. as applicant

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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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