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FDA 510(k)

BONE GRAFT SCREW SYSTEM

K-Number: K973056 · 1997-11-12

ApplicantBicon, Inc.
Decision Date1997-11-12
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONE GRAFT 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 1997-11-12 under 510(k) number K973056. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE GRAFT SCREW SYSTEM?

BONE GRAFT SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-12. The listed applicant is Bicon, Inc.. The 510(k) number is K973056.

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

BONE GRAFT SCREW SYSTEM received FDA 510(k) clearance on 1997-11-12, under 510(k) number K973056.

Who is the listed applicant for BONE GRAFT 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 BONE GRAFT SCREW SYSTEM?

The FDA product code for BONE GRAFT SCREW SYSTEM is DZL.

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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.

K062044THE 5.0 X 6.0MM DENTAL IMPLANTK051091SYNTHOGRAFTK0507124.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANTK050408BICON ORTHODONTIC IMPLANT SYSTEMK031568BICONITE SURFACE TREATMENTK042637THE 5.0 X 6.0MM DENTAL IMPLANT

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Related Devices (Code: DZL)

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.

K254286Guided Bone Regeneration SystemDentalMaster(Xiamen)Medical Technology Co., Ltd.K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbHK251569Bone ScrewOsstem Implant Co., Ltd.K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR SystemProimtech Saglik Urunleri Anonim SirketiK240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger 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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