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FDA 510(k)

3I BIORESORBABLE FIXATION TACK

K-Number: K972480 · 1997-12-23

ApplicantImplant Innovations, Inc.
Decision Date1997-12-23
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

3I BIORESORBABLE FIXATION TACK is the device name listed in this FDA 510(k) record. The listed applicant is Implant Innovations, Inc.. It received FDA 510(k) clearance on 1997-12-23 under 510(k) number K972480. 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 3I BIORESORBABLE FIXATION TACK?

3I BIORESORBABLE FIXATION TACK is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Implant Innovations, Inc.. The 510(k) number is K972480.

When did 3I BIORESORBABLE FIXATION TACK receive FDA 510(k) clearance?

3I BIORESORBABLE FIXATION TACK received FDA 510(k) clearance on 1997-12-23, under 510(k) number K972480.

Who is the listed applicant for 3I BIORESORBABLE FIXATION TACK?

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

What is the FDA product code for 3I BIORESORBABLE FIXATION TACK?

The FDA product code for 3I BIORESORBABLE FIXATION TACK is DZL.

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Other records listing Implant Innovations, 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: 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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