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FDA 510(k)

MODIFICATION TO THE MAESTRO SYSTEM

K-Number: K030463 · 2003-02-26

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2003-02-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO THE MAESTRO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2003-02-26 under 510(k) number K030463. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO THE MAESTRO SYSTEM?

MODIFICATION TO THE MAESTRO SYSTEM is a medical device that received FDA 510(k) clearance on 2003-02-26. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K030463.

When did MODIFICATION TO THE MAESTRO SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO THE MAESTRO SYSTEM received FDA 510(k) clearance on 2003-02-26, under 510(k) number K030463.

Who is the listed applicant for MODIFICATION TO THE MAESTRO SYSTEM?

The FDA 510(k) record lists BioHorizons Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO THE MAESTRO SYSTEM?

The FDA product code for MODIFICATION TO THE MAESTRO SYSTEM is DZE.

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Other records listing BioHorizons Implant Systems, Inc. as applicant

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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