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FDA 510(k)

ISOLA SPINE SYSTEM

K-Number: K944737 · 1995-06-22

ApplicantAcromed Corp.
Decision Date1995-06-22
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISOLA SPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acromed Corp.. It received FDA 510(k) clearance on 1995-06-22 under 510(k) number K944737. 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 ISOLA SPINE SYSTEM?

ISOLA SPINE SYSTEM is a medical device that received FDA 510(k) clearance on 1995-06-22. The listed applicant is Acromed Corp.. The 510(k) number is K944737.

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

ISOLA SPINE SYSTEM received FDA 510(k) clearance on 1995-06-22, under 510(k) number K944737.

Who is the listed applicant for ISOLA SPINE SYSTEM?

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

What is the FDA product code for ISOLA SPINE SYSTEM?

The FDA product code for ISOLA SPINE SYSTEM is MNH. This falls under the ENT category.

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Other records listing Acromed Corp. 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.

K980485ISOLA SPINAL SYSTEMK981714TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEMK981113PEDIATRIC PRCK981274ACROMED TIMX PLATE BASED LOW BACK SYSTEMK980228UNIVERSITY PLATE ANTERIOR SYSTEMK974757KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS

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Related Devices (Code: MNH)

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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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