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FDA 510(k)

MODIFICATION OF: EBI SPINELINK SYSTEM

K-Number: K990999 · 1999-04-14

ApplicantElectro-Biology, Inc.
Decision Date1999-04-14
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF: EBI SPINELINK SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Biology, Inc.. It received FDA 510(k) clearance on 1999-04-14 under 510(k) number K990999. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION OF: EBI SPINELINK SYSTEM?

MODIFICATION OF: EBI SPINELINK SYSTEM is a medical device that received FDA 510(k) clearance on 1999-04-14. The listed applicant is Electro-Biology, Inc.. The 510(k) number is K990999.

When did MODIFICATION OF: EBI SPINELINK SYSTEM receive FDA 510(k) clearance?

MODIFICATION OF: EBI SPINELINK SYSTEM received FDA 510(k) clearance on 1999-04-14, under 510(k) number K990999.

Who is the listed applicant for MODIFICATION OF: EBI SPINELINK SYSTEM?

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

What is the FDA product code for MODIFICATION OF: EBI SPINELINK SYSTEM?

The FDA product code for MODIFICATION OF: EBI SPINELINK SYSTEM is MAI.

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Other records listing Electro-Biology, Inc. as applicant

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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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