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FDA 510(k)

ISOLA(TM) SPINE SYSTEM--EYE ROD

K-Number: K911394 · 1991-06-21

ApplicantAcromed Corp.
Decision Date1991-06-21
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISOLA(TM) SPINE SYSTEM--EYE ROD is the device name listed in this FDA 510(k) record. The listed applicant is Acromed Corp.. It received FDA 510(k) clearance on 1991-06-21 under 510(k) number K911394. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLA(TM) SPINE SYSTEM--EYE ROD?

ISOLA(TM) SPINE SYSTEM--EYE ROD is a medical device that received FDA 510(k) clearance on 1991-06-21. The listed applicant is Acromed Corp.. The 510(k) number is K911394.

When did ISOLA(TM) SPINE SYSTEM--EYE ROD receive FDA 510(k) clearance?

ISOLA(TM) SPINE SYSTEM--EYE ROD received FDA 510(k) clearance on 1991-06-21, under 510(k) number K911394.

Who is the listed applicant for ISOLA(TM) SPINE SYSTEM--EYE ROD?

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(TM) SPINE SYSTEM--EYE ROD?

The FDA product code for ISOLA(TM) SPINE SYSTEM--EYE ROD is KWP.

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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: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

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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