FDA 510(k)

Overwatch Spine System

K-Number: K161842 · 2016-10-13

Decision Date2016-10-13

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Overwatch Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Amendia, Inc.. It received FDA 510(k) clearance on 2016-10-13 under 510(k) number K161842. 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 Overwatch Spine System?

Overwatch Spine System is a medical device that received FDA 510(k) clearance on 2016-10-13. The listed applicant is Amendia, Inc.. The 510(k) number is K161842.

When did Overwatch Spine System receive FDA 510(k) clearance?

Overwatch Spine System received FDA 510(k) clearance on 2016-10-13, under 510(k) number K161842.

Who is the listed applicant for Overwatch Spine System?

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

What is the FDA product code for Overwatch Spine System?

The FDA product code for Overwatch Spine System is NKB.

Other records listing Amendia, 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.

K160924Amendia Interbody Fusion Devices K152920Savannah-T® Pedicle Screw System K153152Syzygy Stabilization System K160291Optimus ALIF System K152972Amendia Stand-Alone Cervical System K151310Amendia Interbody Fusion Devices

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Related Devices (Code: NKB)

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLC 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.O K253045“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.