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FDA 510(k)

3D-SPINE

K-Number: K962377 · 1996-09-03

ApplicantSkill Technologies, Inc.
Decision Date1996-09-03
Product CodeKQX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

3D-SPINE is the device name listed in this FDA 510(k) record. The listed applicant is Skill Technologies, Inc.. It received FDA 510(k) clearance on 1996-09-03 under 510(k) number K962377. The device is classified under product code KQX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D-SPINE?

3D-SPINE is a medical device that received FDA 510(k) clearance on 1996-09-03. The listed applicant is Skill Technologies, Inc.. The 510(k) number is K962377.

When did 3D-SPINE receive FDA 510(k) clearance?

3D-SPINE received FDA 510(k) clearance on 1996-09-03, under 510(k) number K962377.

Who is the listed applicant for 3D-SPINE?

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

What is the FDA product code for 3D-SPINE?

The FDA product code for 3D-SPINE is KQX.

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Related Devices (Code: KQX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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