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FDA 510(k)

SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES

K-Number: K070294 · 2007-03-01

ApplicantSynthes (Usa)
Decision Date2007-03-01
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2007-03-01 under 510(k) number K070294. 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 SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES?

SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES is a medical device that received FDA 510(k) clearance on 2007-03-01. The listed applicant is Synthes (Usa). The 510(k) number is K070294.

When did SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES receive FDA 510(k) clearance?

SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES received FDA 510(k) clearance on 2007-03-01, under 510(k) number K070294.

Who is the listed applicant for SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES?

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

What is the FDA product code for SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES?

The FDA product code for SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES is HSB.

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Other records listing Synthes (Usa) as applicant

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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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