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FDA 510(k)

T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP

K-Number: K112059 · 2011-08-08

ApplicantStryker
Decision Date2011-08-08
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2011-08-08 under 510(k) number K112059. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP?

T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP is a medical device that received FDA 510(k) clearance on 2011-08-08. The listed applicant is Stryker. The 510(k) number is K112059.

When did T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP receive FDA 510(k) clearance?

T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP received FDA 510(k) clearance on 2011-08-08, under 510(k) number K112059.

Who is the listed applicant for T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP?

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

What is the FDA product code for T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP?

The FDA product code for T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP is HSB.

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Related Devices (Code: HSB)

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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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