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FDA 510(k)

SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT

K-Number: K123240 · 2013-02-14

ApplicantArthroCare Corporation
Decision Date2013-02-14
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2013-02-14 under 510(k) number K123240. 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 SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT?

SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT is a medical device that received FDA 510(k) clearance on 2013-02-14. The listed applicant is ArthroCare Corporation. The 510(k) number is K123240.

When did SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT receive FDA 510(k) clearance?

SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT received FDA 510(k) clearance on 2013-02-14, under 510(k) number K123240.

Who is the listed applicant for SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT?

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

What is the FDA product code for SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT?

The FDA product code for SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT is MBI.

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Related Devices (Code: MBI)

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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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