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FDA 510(k)

EBI SPINELINK SYSTEM

K-Number: K964797 · 1997-05-02

ApplicantElectro-Biology, Inc.
Decision Date1997-05-02
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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 1997-05-02 under 510(k) number K964797. 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 EBI SPINELINK SYSTEM?

EBI SPINELINK SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-02. The listed applicant is Electro-Biology, Inc.. The 510(k) number is K964797.

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

EBI SPINELINK SYSTEM received FDA 510(k) clearance on 1997-05-02, under 510(k) number K964797.

Who is the listed applicant for 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 EBI SPINELINK SYSTEM?

The FDA product code for EBI SPINELINK SYSTEM is KWQ.

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Other records listing Electro-Biology, Inc. 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.

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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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