FDA 510(k)

VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX

K-Number: K111983 · 2011-11-18

ApplicantZimmer Trabecular Metal Technology

Decision Date2011-11-18

Product CodeODP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Trabecular Metal Technology. It received FDA 510(k) clearance on 2011-11-18 under 510(k) number K111983. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX?

VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX is a medical device that received FDA 510(k) clearance on 2011-11-18. The listed applicant is Zimmer Trabecular Metal Technology. The 510(k) number is K111983.

When did VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX receive FDA 510(k) clearance?

VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX received FDA 510(k) clearance on 2011-11-18, under 510(k) number K111983.

Who is the listed applicant for VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX?

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

What is the FDA product code for VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX?

The FDA product code for VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX is ODP.

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Other records listing Zimmer Trabecular Metal Technology as applicant

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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.