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FDA 510(k)

Intra-Lock Bone Fixation System

K-Number: K171831 · 2017-10-26

ApplicantIntra-Lock International, Inc.
Decision Date2017-10-26
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Intra-Lock Bone Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Intra-Lock International, Inc.. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K171831. 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 Intra-Lock Bone Fixation System?

Intra-Lock Bone Fixation System is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Intra-Lock International, Inc.. The 510(k) number is K171831.

When did Intra-Lock Bone Fixation System receive FDA 510(k) clearance?

Intra-Lock Bone Fixation System received FDA 510(k) clearance on 2017-10-26, under 510(k) number K171831.

Who is the listed applicant for Intra-Lock Bone Fixation System?

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

What is the FDA product code for Intra-Lock Bone Fixation System?

The FDA product code for Intra-Lock Bone Fixation System is DZL.

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.

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 GmbHK233721KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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