FDA 510(k)

STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937

K-Number: K063584 · 2007-05-09

ApplicantRegeneration Technologies, Inc.

Decision Date2007-05-09

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 is the device name listed in this FDA 510(k) record. The listed applicant is Regeneration Technologies, Inc.. It received FDA 510(k) clearance on 2007-05-09 under 510(k) number K063584. 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.

Frequently Asked Questions

What is the STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937?

STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 is a medical device that received FDA 510(k) clearance on 2007-05-09. The listed applicant is Regeneration Technologies, Inc.. The 510(k) number is K063584.

When did STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 receive FDA 510(k) clearance?

STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 received FDA 510(k) clearance on 2007-05-09, under 510(k) number K063584.

Who is the listed applicant for STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937?

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

What is the FDA product code for STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937?

The FDA product code for STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 is HWC. This falls under the Cardiovascular category.

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Other records listing Regeneration Technologies, 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.