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FDA 510(k)

STAPLETAC2 BONE ANCHOR SYSTEM

K-Number: K000279 · 2000-03-01

ApplicantAmerican Medical Systems, Inc.
Decision Date2000-03-01
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STAPLETAC2 BONE ANCHOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Systems, Inc.. It received FDA 510(k) clearance on 2000-03-01 under 510(k) number K000279. 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 STAPLETAC2 BONE ANCHOR SYSTEM?

STAPLETAC2 BONE ANCHOR SYSTEM is a medical device that received FDA 510(k) clearance on 2000-03-01. The listed applicant is American Medical Systems, Inc.. The 510(k) number is K000279.

When did STAPLETAC2 BONE ANCHOR SYSTEM receive FDA 510(k) clearance?

STAPLETAC2 BONE ANCHOR SYSTEM received FDA 510(k) clearance on 2000-03-01, under 510(k) number K000279.

Who is the listed applicant for STAPLETAC2 BONE ANCHOR SYSTEM?

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

What is the FDA product code for STAPLETAC2 BONE ANCHOR SYSTEM?

The FDA product code for STAPLETAC2 BONE ANCHOR SYSTEM is 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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