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FDA 510(k)

TITANIUIM BONE SCREW

K-Number: K853869 · 1985-12-09

ApplicantGeorge Tiemann & Co.
Decision Date1985-12-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TITANIUIM BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is George Tiemann & Co.. It received FDA 510(k) clearance on 1985-12-09 under 510(k) number K853869. 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 TITANIUIM BONE SCREW?

TITANIUIM BONE SCREW is a medical device that received FDA 510(k) clearance on 1985-12-09. The listed applicant is George Tiemann & Co.. The 510(k) number is K853869.

When did TITANIUIM BONE SCREW receive FDA 510(k) clearance?

TITANIUIM BONE SCREW received FDA 510(k) clearance on 1985-12-09, under 510(k) number K853869.

Who is the listed applicant for TITANIUIM BONE SCREW?

The FDA 510(k) record lists George Tiemann & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TITANIUIM BONE SCREW?

The FDA product code for TITANIUIM BONE SCREW is HWC. This falls under the Cardiovascular category.

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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

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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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