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FDA 510(k)

AMISTEM AND QUADRA - LINE EXTENSION

K-Number: K121011 · 2012-06-08

ApplicantMedacta International
Decision Date2012-06-08
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AMISTEM AND QUADRA - LINE EXTENSION is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International. It received FDA 510(k) clearance on 2012-06-08 under 510(k) number K121011. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMISTEM AND QUADRA - LINE EXTENSION?

AMISTEM AND QUADRA - LINE EXTENSION is a medical device that received FDA 510(k) clearance on 2012-06-08. The listed applicant is Medacta International. The 510(k) number is K121011.

When did AMISTEM AND QUADRA - LINE EXTENSION receive FDA 510(k) clearance?

AMISTEM AND QUADRA - LINE EXTENSION received FDA 510(k) clearance on 2012-06-08, under 510(k) number K121011.

Who is the listed applicant for AMISTEM AND QUADRA - LINE EXTENSION?

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

What is the FDA product code for AMISTEM AND QUADRA - LINE EXTENSION?

The FDA product code for AMISTEM AND QUADRA - LINE EXTENSION is LZO.

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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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