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FDA 510(k)

BICON BONE SCREW SYSTEM

K-Number: K982488 · 1999-01-26

ApplicantBicon, Inc.
Decision Date1999-01-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BICON BONE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bicon, Inc.. It received FDA 510(k) clearance on 1999-01-26 under 510(k) number K982488. 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 BICON BONE SCREW SYSTEM?

BICON BONE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-26. The listed applicant is Bicon, Inc.. The 510(k) number is K982488.

When did BICON BONE SCREW SYSTEM receive FDA 510(k) clearance?

BICON BONE SCREW SYSTEM received FDA 510(k) clearance on 1999-01-26, under 510(k) number K982488.

Who is the listed applicant for BICON BONE SCREW SYSTEM?

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

What is the FDA product code for BICON BONE SCREW SYSTEM?

The FDA product code for BICON BONE SCREW SYSTEM is DZE.

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Other records listing Bicon, Inc. 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.

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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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