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FDA 510(k)

MODIFICATION TO ISOLA SPINAL SYSTEM

K-Number: K993030 · 1999-12-29

ApplicantDepuyacromed
Decision Date1999-12-29
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ISOLA SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuyacromed. It received FDA 510(k) clearance on 1999-12-29 under 510(k) number K993030. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ISOLA SPINAL SYSTEM?

MODIFICATION TO ISOLA SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1999-12-29. The listed applicant is Depuyacromed. The 510(k) number is K993030.

When did MODIFICATION TO ISOLA SPINAL SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO ISOLA SPINAL SYSTEM received FDA 510(k) clearance on 1999-12-29, under 510(k) number K993030.

Who is the listed applicant for MODIFICATION TO ISOLA SPINAL SYSTEM?

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

What is the FDA product code for MODIFICATION TO ISOLA SPINAL SYSTEM?

The FDA product code for MODIFICATION TO ISOLA SPINAL SYSTEM is KWQ.

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Other records listing Depuyacromed as applicant

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Related Devices (Code: 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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