FDA 510(k)

BONE-LOCK

K-Number: K954030 · 1997-11-14

Decision Date1997-11-14

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

BONE-LOCK is the device name listed in this FDA 510(k) record. The listed applicant is Leibinger GmbH. It received FDA 510(k) clearance on 1997-11-14 under 510(k) number K954030. 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 BONE-LOCK?

BONE-LOCK is a medical device that received FDA 510(k) clearance on 1997-11-14. The listed applicant is Leibinger GmbH. The 510(k) number is K954030.

When did BONE-LOCK receive FDA 510(k) clearance?

BONE-LOCK received FDA 510(k) clearance on 1997-11-14, under 510(k) number K954030.

Who is the listed applicant for BONE-LOCK?

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

What is the FDA product code for BONE-LOCK?

The FDA product code for BONE-LOCK is DZE.

Other records listing Leibinger GmbH 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.

K946033LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE K924685STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM

Related Devices (Code: DZE)

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC K260463ZEROS 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.