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FDA 510(k)

TITANIUM ALLOY BONE SCREWS

K-Number: K970549 · 1997-04-30

ApplicantAesculap, Inc.
Decision Date1997-04-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

TITANIUM ALLOY BONE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 1997-04-30 under 510(k) number K970549. 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 TITANIUM ALLOY BONE SCREWS?

TITANIUM ALLOY BONE SCREWS is a medical device that received FDA 510(k) clearance on 1997-04-30. The listed applicant is Aesculap, Inc.. The 510(k) number is K970549.

When did TITANIUM ALLOY BONE SCREWS receive FDA 510(k) clearance?

TITANIUM ALLOY BONE SCREWS received FDA 510(k) clearance on 1997-04-30, under 510(k) number K970549.

Who is the listed applicant for TITANIUM ALLOY BONE SCREWS?

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

What is the FDA product code for TITANIUM ALLOY BONE SCREWS?

The FDA product code for TITANIUM ALLOY BONE SCREWS is HWC. This falls under the Cardiovascular category.

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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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