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FDA 510(k)

MINIFIX BALL MINIFIX ONE

K-Number: K122052 · 2012-11-28

ApplicantBonafix Surgical and Dental Implants, LLC
Decision Date2012-11-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINIFIX BALL MINIFIX ONE is the device name listed in this FDA 510(k) record. The listed applicant is Bonafix Surgical and Dental Implants, LLC. It received FDA 510(k) clearance on 2012-11-28 under 510(k) number K122052. 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 MINIFIX BALL MINIFIX ONE?

MINIFIX BALL MINIFIX ONE is a medical device that received FDA 510(k) clearance on 2012-11-28. The listed applicant is Bonafix Surgical and Dental Implants, LLC. The 510(k) number is K122052.

When did MINIFIX BALL MINIFIX ONE receive FDA 510(k) clearance?

MINIFIX BALL MINIFIX ONE received FDA 510(k) clearance on 2012-11-28, under 510(k) number K122052.

Who is the listed applicant for MINIFIX BALL MINIFIX ONE?

The FDA 510(k) record lists Bonafix Surgical and Dental Implants, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINIFIX BALL MINIFIX ONE?

The FDA product code for MINIFIX BALL MINIFIX ONE is DZE.

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 Bonafix Surgical and Dental Implants, LLC 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.

K113650ORTHOFIX SCREW

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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