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FDA 510(k)

OREGON FIXATION SCREW

K-Number: K910976 · 1992-01-13

ApplicantAcu Med, Inc.
Decision Date1992-01-13
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OREGON FIXATION SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1992-01-13 under 510(k) number K910976. 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 OREGON FIXATION SCREW?

OREGON FIXATION SCREW is a medical device that received FDA 510(k) clearance on 1992-01-13. The listed applicant is Acu Med, Inc.. The 510(k) number is K910976.

When did OREGON FIXATION SCREW receive FDA 510(k) clearance?

OREGON FIXATION SCREW received FDA 510(k) clearance on 1992-01-13, under 510(k) number K910976.

Who is the listed applicant for OREGON FIXATION SCREW?

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

What is the FDA product code for OREGON FIXATION SCREW?

The FDA product code for OREGON FIXATION SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Acu Med, Inc. as applicant

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Related Devices (Code: HWC)

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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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