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FDA 510(k)

ALPHA ORTHOPAEDICS AT2 SYSTEM

K-Number: K082956 · 2008-12-18

ApplicantAlpha Orthopaedics
Decision Date2008-12-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALPHA ORTHOPAEDICS AT2 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 2008-12-18 under 510(k) number K082956. 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 AT2 SYSTEM?

ALPHA ORTHOPAEDICS AT2 SYSTEM is a medical device that received FDA 510(k) clearance on 2008-12-18. The listed applicant is Alpha Orthopaedics. The 510(k) number is K082956.

When did ALPHA ORTHOPAEDICS AT2 SYSTEM receive FDA 510(k) clearance?

ALPHA ORTHOPAEDICS AT2 SYSTEM received FDA 510(k) clearance on 2008-12-18, under 510(k) number K082956.

Who is the listed applicant for ALPHA ORTHOPAEDICS AT2 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 AT2 SYSTEM?

The FDA product code for ALPHA ORTHOPAEDICS AT2 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.

K094041ALPHA ORTHOPAEDICS AT3 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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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