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FDA 510(k)

INSTINCT JAVA SYSTEM

K-Number: K122592 · 2013-01-04

ApplicantZimmer Spine
Decision Date2013-01-04
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INSTINCT JAVA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Spine. It received FDA 510(k) clearance on 2013-01-04 under 510(k) number K122592. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTINCT JAVA SYSTEM?

INSTINCT JAVA SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-04. The listed applicant is Zimmer Spine. The 510(k) number is K122592.

When did INSTINCT JAVA SYSTEM receive FDA 510(k) clearance?

INSTINCT JAVA SYSTEM received FDA 510(k) clearance on 2013-01-04, under 510(k) number K122592.

Who is the listed applicant for INSTINCT JAVA SYSTEM?

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

What is the FDA product code for INSTINCT JAVA SYSTEM?

The FDA product code for INSTINCT JAVA SYSTEM is MNH. This falls under the ENT category.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Zimmer Spine 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.

K123552INSTINCT JAVA SYSTEMK113270INSTINCT JAVA SYSTEMK111301INSTINCT JAVA SYSTEMK110348UNIVERSAL CLAMP SPINAL FIXATION SYSTEM

Related Devices (Code: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S 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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