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FDA 510(k)

KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES

K-Number: K070561 · 2007-05-25

ApplicantTeleflex Medical
Decision Date2007-05-25
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical. It received FDA 510(k) clearance on 2007-05-25 under 510(k) number K070561. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES?

KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES is a medical device that received FDA 510(k) clearance on 2007-05-25. The listed applicant is Teleflex Medical. The 510(k) number is K070561.

When did KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES receive FDA 510(k) clearance?

KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES received FDA 510(k) clearance on 2007-05-25, under 510(k) number K070561.

Who is the listed applicant for KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES?

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

What is the FDA product code for KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES?

The FDA product code for KMEDIC INTERNAL/EXTERNAL FIXATION DEVICES is HTY.

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Other records listing Teleflex Medical as applicant

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Related Devices (Code: HTY)

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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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