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FDA 510(k)

STRYKER WEDGE INTERFERENCE SCREW SYSTEM

K-Number: K972233 · 1997-08-05

ApplicantStryker Endoscopy
Decision Date1997-08-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRYKER WEDGE INTERFERENCE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 1997-08-05 under 510(k) number K972233. 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 STRYKER WEDGE INTERFERENCE SCREW SYSTEM?

STRYKER WEDGE INTERFERENCE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1997-08-05. The listed applicant is Stryker Endoscopy. The 510(k) number is K972233.

When did STRYKER WEDGE INTERFERENCE SCREW SYSTEM receive FDA 510(k) clearance?

STRYKER WEDGE INTERFERENCE SCREW SYSTEM received FDA 510(k) clearance on 1997-08-05, under 510(k) number K972233.

Who is the listed applicant for STRYKER WEDGE INTERFERENCE SCREW SYSTEM?

The FDA 510(k) record lists Stryker Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STRYKER WEDGE INTERFERENCE SCREW SYSTEM?

The FDA product code for STRYKER WEDGE INTERFERENCE SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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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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