Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALPHA BIO BONE FIXATION SCREW SYSTEM

K-Number: K063769 · 2007-03-30

ApplicantAlpha-Bio Tec , Ltd.
Decision Date2007-03-30
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALPHA BIO BONE FIXATION SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alpha-Bio Tec , Ltd.. It received FDA 510(k) clearance on 2007-03-30 under 510(k) number K063769. 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 ALPHA BIO BONE FIXATION SCREW SYSTEM?

ALPHA BIO BONE FIXATION SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-30. The listed applicant is Alpha-Bio Tec , Ltd.. The 510(k) number is K063769.

When did ALPHA BIO BONE FIXATION SCREW SYSTEM receive FDA 510(k) clearance?

ALPHA BIO BONE FIXATION SCREW SYSTEM received FDA 510(k) clearance on 2007-03-30, under 510(k) number K063769.

Who is the listed applicant for ALPHA BIO BONE FIXATION SCREW SYSTEM?

The FDA 510(k) record lists Alpha-Bio Tec , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA BIO BONE FIXATION SCREW SYSTEM?

The FDA product code for ALPHA BIO BONE FIXATION SCREW SYSTEM is DZL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alpha-Bio Tec , Ltd. 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.

K063770ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEMK063364ALPHA BIO DENTAL IMPLANT SYSTEM

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.

↑