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FDA 510(k)

STRYKER ACL INTERFERENCE SCREW SYSTEM

K-Number: K952460 · 1995-09-28

ApplicantStryker Endoscopy
Decision Date1995-09-28
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRYKER ACL 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 1995-09-28 under 510(k) number K952460. 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 ACL INTERFERENCE SCREW SYSTEM?

STRYKER ACL INTERFERENCE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1995-09-28. The listed applicant is Stryker Endoscopy. The 510(k) number is K952460.

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

STRYKER ACL INTERFERENCE SCREW SYSTEM received FDA 510(k) clearance on 1995-09-28, under 510(k) number K952460.

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

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

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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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