FDA 510(k)

CI KNEE, CI MI TKR

K-Number: K052966 · 2006-02-13

Decision Date2006-02-13

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CI KNEE, CI MI TKR is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2006-02-13 under 510(k) number K052966. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CI KNEE, CI MI TKR?

CI KNEE, CI MI TKR is a medical device that received FDA 510(k) clearance on 2006-02-13. The listed applicant is Brainlab AG. The 510(k) number is K052966.

When did CI KNEE, CI MI TKR receive FDA 510(k) clearance?

CI KNEE, CI MI TKR received FDA 510(k) clearance on 2006-02-13, under 510(k) number K052966.

Who is the listed applicant for CI KNEE, CI MI TKR?

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

What is the FDA product code for CI KNEE, CI MI TKR?

The FDA product code for CI KNEE, CI MI TKR is HAW.

Other records listing Brainlab AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.