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FDA 510(k)

K2 BONE SCREW SYSTEM

K-Number: K960537 · 1996-03-25

ApplicantKinetikos Medical, Inc.
Decision Date1996-03-25
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

K2 BONE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kinetikos Medical, Inc.. It received FDA 510(k) clearance on 1996-03-25 under 510(k) number K960537. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the K2 BONE SCREW SYSTEM?

K2 BONE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-25. The listed applicant is Kinetikos Medical, Inc.. The 510(k) number is K960537.

When did K2 BONE SCREW SYSTEM receive FDA 510(k) clearance?

K2 BONE SCREW SYSTEM received FDA 510(k) clearance on 1996-03-25, under 510(k) number K960537.

Who is the listed applicant for K2 BONE SCREW SYSTEM?

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

What is the FDA product code for K2 BONE SCREW SYSTEM?

The FDA product code for K2 BONE SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Kinetikos Medical, 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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