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FDA 510(k)

OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS

K-Number: K950652 · 1995-06-22

ApplicantOsteotech, Inc.
Decision Date1995-06-22
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Osteotech, Inc.. It received FDA 510(k) clearance on 1995-06-22 under 510(k) number K950652. 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 OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS?

OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS is a medical device that received FDA 510(k) clearance on 1995-06-22. The listed applicant is Osteotech, Inc.. The 510(k) number is K950652.

When did OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS receive FDA 510(k) clearance?

OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS received FDA 510(k) clearance on 1995-06-22, under 510(k) number K950652.

Who is the listed applicant for OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS?

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

What is the FDA product code for OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS?

The FDA product code for OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS is HWC. This falls under the Cardiovascular category.

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Other records listing Osteotech, 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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