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FDA 510(k)

STATAK SOFT TISSUE ATTACHMENT DEVICE

K-Number: K962397 · 1996-08-27

ApplicantZimmer, Inc.
Decision Date1996-08-27
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STATAK SOFT TISSUE ATTACHMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1996-08-27 under 510(k) number K962397. 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 STATAK SOFT TISSUE ATTACHMENT DEVICE?

STATAK SOFT TISSUE ATTACHMENT DEVICE is a medical device that received FDA 510(k) clearance on 1996-08-27. The listed applicant is Zimmer, Inc.. The 510(k) number is K962397.

When did STATAK SOFT TISSUE ATTACHMENT DEVICE receive FDA 510(k) clearance?

STATAK SOFT TISSUE ATTACHMENT DEVICE received FDA 510(k) clearance on 1996-08-27, under 510(k) number K962397.

Who is the listed applicant for STATAK SOFT TISSUE ATTACHMENT DEVICE?

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

What is the FDA product code for STATAK SOFT TISSUE ATTACHMENT DEVICE?

The FDA product code for STATAK SOFT TISSUE ATTACHMENT DEVICE 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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