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FDA 510(k)

AUTOGENESIS(TM) AUTOMATOR

K-Number: K905514 · 1991-04-02

ApplicantAdvanced Biosearch Assn.
Decision Date1991-04-02
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AUTOGENESIS(TM) AUTOMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biosearch Assn.. It received FDA 510(k) clearance on 1991-04-02 under 510(k) number K905514. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOGENESIS(TM) AUTOMATOR?

AUTOGENESIS(TM) AUTOMATOR is a medical device that received FDA 510(k) clearance on 1991-04-02. The listed applicant is Advanced Biosearch Assn.. The 510(k) number is K905514.

When did AUTOGENESIS(TM) AUTOMATOR receive FDA 510(k) clearance?

AUTOGENESIS(TM) AUTOMATOR received FDA 510(k) clearance on 1991-04-02, under 510(k) number K905514.

Who is the listed applicant for AUTOGENESIS(TM) AUTOMATOR?

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

What is the FDA product code for AUTOGENESIS(TM) AUTOMATOR?

The FDA product code for AUTOGENESIS(TM) AUTOMATOR is KTT.

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Other records listing Advanced Biosearch Assn. 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.

K883888CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.K854770MARTIN LAMINAR OSTEOSYNTHESIS SYSTEMK855030CHAMPY BONE PLATES & BONE SCREWSK855031MANUAL SURGICAL INSTRUMENTS & ACCESS.CHAMPY BONE PK853916P.M. HIP-FEMORAL PROSTHESISK852839FREEMAN HIP

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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