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FDA 510(k)

ENNOVATE Spinal System

K-Number: K162134 · 2016-12-14

ApplicantAesculap Implant Systems, LLC
Decision Date2016-12-14
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENNOVATE Spinal System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2016-12-14 under 510(k) number K162134. 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 ENNOVATE Spinal System?

ENNOVATE Spinal System is a medical device that received FDA 510(k) clearance on 2016-12-14. The listed applicant is Aesculap Implant Systems, LLC. The 510(k) number is K162134.

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

ENNOVATE Spinal System received FDA 510(k) clearance on 2016-12-14, under 510(k) number K162134.

Who is the listed applicant for ENNOVATE Spinal System?

The FDA 510(k) record lists Aesculap Implant Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENNOVATE Spinal System?

The FDA product code for ENNOVATE Spinal System is NKB.

Other records listing Aesculap Implant Systems, 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.

K213871Ennovate Cervical Spinal and Occiput SystemK210963ENNOVATE Spinal SystemK180433ENNOVATE®K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsK153629ArcadiusXP C Spinal SystemK153396Aesculap OrthoPilot Next Generation

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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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