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FDA 510(k)

METS MODULAR TOTAL FEMUR

K-Number: K121055 · 2012-09-19

ApplicantStanmore Implants Worldwide , Ltd.
Decision Date2012-09-19
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METS MODULAR TOTAL FEMUR is the device name listed in this FDA 510(k) record. The listed applicant is Stanmore Implants Worldwide , Ltd.. It received FDA 510(k) clearance on 2012-09-19 under 510(k) number K121055. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METS MODULAR TOTAL FEMUR?

METS MODULAR TOTAL FEMUR is a medical device that received FDA 510(k) clearance on 2012-09-19. The listed applicant is Stanmore Implants Worldwide , Ltd.. The 510(k) number is K121055.

When did METS MODULAR TOTAL FEMUR receive FDA 510(k) clearance?

METS MODULAR TOTAL FEMUR received FDA 510(k) clearance on 2012-09-19, under 510(k) number K121055.

Who is the listed applicant for METS MODULAR TOTAL FEMUR?

The FDA 510(k) record lists Stanmore Implants Worldwide , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METS MODULAR TOTAL FEMUR?

The FDA product code for METS MODULAR TOTAL FEMUR is JDI.

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Other records listing Stanmore Implants Worldwide , Ltd. 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.

K121765SCULPTOR ROBOTIC GUIDANCE ARM (RGA)K121056METS MODULAR PROXIMAL FEMURK121029METS MODULAR DISTAL FEMURK120992METS SMILES TOTAL KNEE REPLACEMENTK092138JTS EXTENDEABLE IMPLANT

Related Devices (Code: JDI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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