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FDA 510(k)

U.S. TYPE CRUCIATE SLOT BONE SCREW

K-Number: K905333 · 1991-01-04

ApplicantO'Tec Corp.
Decision Date1991-01-04
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

U.S. TYPE CRUCIATE SLOT BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is O'Tec Corp.. It received FDA 510(k) clearance on 1991-01-04 under 510(k) number K905333. 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 U.S. TYPE CRUCIATE SLOT BONE SCREW?

U.S. TYPE CRUCIATE SLOT BONE SCREW is a medical device that received FDA 510(k) clearance on 1991-01-04. The listed applicant is O'Tec Corp.. The 510(k) number is K905333.

When did U.S. TYPE CRUCIATE SLOT BONE SCREW receive FDA 510(k) clearance?

U.S. TYPE CRUCIATE SLOT BONE SCREW received FDA 510(k) clearance on 1991-01-04, under 510(k) number K905333.

Who is the listed applicant for U.S. TYPE CRUCIATE SLOT BONE SCREW?

The FDA 510(k) record lists O'Tec Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U.S. TYPE CRUCIATE SLOT BONE SCREW?

The FDA product code for U.S. TYPE CRUCIATE SLOT BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing O'Tec Corp. 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.

K943293SCC22/ SCC26 SHOWER COMMODE CHAIRK910093FUTURA FEMORAL HIP STEMK905358CANCELLOUS SCREWK905355BROAD SELF-COMPRESSING PLATEK905347HAGIE PINK905357CORTICAL BONE SCREW (EUROPEAN STYLE)

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Related Devices (Code: HWC)

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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