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FDA 510(k)

ALPHA ORTHOPAEDICS AT3 SYSTEM

K-Number: K094041 · 2010-04-07

ApplicantAlpha Orthopaedics
Decision Date2010-04-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALPHA ORTHOPAEDICS AT3 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Orthopaedics. It received FDA 510(k) clearance on 2010-04-07 under 510(k) number K094041. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA ORTHOPAEDICS AT3 SYSTEM?

ALPHA ORTHOPAEDICS AT3 SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-07. The listed applicant is Alpha Orthopaedics. The 510(k) number is K094041.

When did ALPHA ORTHOPAEDICS AT3 SYSTEM receive FDA 510(k) clearance?

ALPHA ORTHOPAEDICS AT3 SYSTEM received FDA 510(k) clearance on 2010-04-07, under 510(k) number K094041.

Who is the listed applicant for ALPHA ORTHOPAEDICS AT3 SYSTEM?

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

What is the FDA product code for ALPHA ORTHOPAEDICS AT3 SYSTEM?

The FDA product code for ALPHA ORTHOPAEDICS AT3 SYSTEM is GEI.

Related Clinical Trials

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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Other records listing Alpha Orthopaedics 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.

K082956ALPHA ORTHOPAEDICS AT2 SYSTEM

Related Devices (Code: GEI)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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