Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AESCULAP SPINE SYSTEM EVOLUTION

K-Number: K980484 · 1998-10-02

ApplicantAesculap, Inc.
Decision Date1998-10-02
Product CodeMNI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AESCULAP SPINE SYSTEM EVOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 1998-10-02 under 510(k) number K980484. The device is classified under product code MNI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESCULAP SPINE SYSTEM EVOLUTION?

AESCULAP SPINE SYSTEM EVOLUTION is a medical device that received FDA 510(k) clearance on 1998-10-02. The listed applicant is Aesculap, Inc.. The 510(k) number is K980484.

When did AESCULAP SPINE SYSTEM EVOLUTION receive FDA 510(k) clearance?

AESCULAP SPINE SYSTEM EVOLUTION received FDA 510(k) clearance on 1998-10-02, under 510(k) number K980484.

Who is the listed applicant for AESCULAP SPINE SYSTEM EVOLUTION?

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

What is the FDA product code for AESCULAP SPINE SYSTEM EVOLUTION?

The FDA product code for AESCULAP SPINE SYSTEM EVOLUTION is MNI.

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 Aesculap, 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.

K242762Aesculap Aicon® Series Container SystemK242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetK223596SQ.line KERRISONK214041Aesculap AICON ContainerK211572Aesculap Slim Clip ApplierK203739ELAN 4 Electro Motor System

View all 195 devices →

Related Devices (Code: MNI)

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.

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. , Ltd.K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd.K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc.K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.K160320PremierShandong Weigao Orthopaedic Device 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.

↑