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FDA 510(k)

NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER

K-Number: K051069 · 2005-06-29

ApplicantArthrotek, Inc.
Decision Date2005-06-29
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Arthrotek, Inc.. It received FDA 510(k) clearance on 2005-06-29 under 510(k) number K051069. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER?

NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER is a medical device that received FDA 510(k) clearance on 2005-06-29. The listed applicant is Arthrotek, Inc.. The 510(k) number is K051069.

When did NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER receive FDA 510(k) clearance?

NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER received FDA 510(k) clearance on 2005-06-29, under 510(k) number K051069.

Who is the listed applicant for NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER?

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

What is the FDA product code for NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER?

The FDA product code for NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER is MBI.

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Related Devices (Code: MBI)

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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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