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FDA 510(k)

FEMORAL INTRAFIX SCREW AND SHEATH

K-Number: K063577 · 2007-01-25

ApplicantJohnson & Johnson Company
Decision Date2007-01-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FEMORAL INTRAFIX SCREW AND SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Company. It received FDA 510(k) clearance on 2007-01-25 under 510(k) number K063577. 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 FEMORAL INTRAFIX SCREW AND SHEATH?

FEMORAL INTRAFIX SCREW AND SHEATH is a medical device that received FDA 510(k) clearance on 2007-01-25. The listed applicant is Johnson & Johnson Company. The 510(k) number is K063577.

When did FEMORAL INTRAFIX SCREW AND SHEATH receive FDA 510(k) clearance?

FEMORAL INTRAFIX SCREW AND SHEATH received FDA 510(k) clearance on 2007-01-25, under 510(k) number K063577.

Who is the listed applicant for FEMORAL INTRAFIX SCREW AND SHEATH?

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

What is the FDA product code for FEMORAL INTRAFIX SCREW AND SHEATH?

The FDA product code for FEMORAL INTRAFIX SCREW AND SHEATH is MBI.

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Other records listing Johnson & Johnson Company 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.

K060914TRIDENT ANCHOR

Related Devices (Code: MBI)

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.

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