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FDA 510(k)

KANEDA SR ANTERIOR SPINAL SYSTEM

K-Number: K971248 · 1997-06-11

ApplicantAcromed Corp.
Decision Date1997-06-11
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

KANEDA SR ANTERIOR SPINAL 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 1997-06-11 under 510(k) number K971248. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the KANEDA SR ANTERIOR SPINAL SYSTEM?

KANEDA SR ANTERIOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-11. The listed applicant is Acromed Corp.. The 510(k) number is K971248.

When did KANEDA SR ANTERIOR SPINAL SYSTEM receive FDA 510(k) clearance?

KANEDA SR ANTERIOR SPINAL SYSTEM received FDA 510(k) clearance on 1997-06-11, under 510(k) number K971248.

Who is the listed applicant for KANEDA SR ANTERIOR SPINAL 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 KANEDA SR ANTERIOR SPINAL SYSTEM?

The FDA product code for KANEDA SR ANTERIOR SPINAL SYSTEM is KWQ.

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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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