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FDA 510(k)

CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW

K-Number: K915187 · 1991-12-19

ApplicantTechmedica, Inc.
Decision Date1991-12-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Techmedica, Inc.. It received FDA 510(k) clearance on 1991-12-19 under 510(k) number K915187. 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 CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW?

CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW is a medical device that received FDA 510(k) clearance on 1991-12-19. The listed applicant is Techmedica, Inc.. The 510(k) number is K915187.

When did CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW receive FDA 510(k) clearance?

CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW received FDA 510(k) clearance on 1991-12-19, under 510(k) number K915187.

Who is the listed applicant for CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW?

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

What is the FDA product code for CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW?

The FDA product code for CANCELLOUS BONE-L.P. AND CORTICAL BONE SCREW 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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