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)

EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS

K-Number: K992367 · 1999-09-23

ApplicantElectro-Biology, Inc.
Decision Date1999-09-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Biology, Inc.. It received FDA 510(k) clearance on 1999-09-23 under 510(k) number K992367. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS?

EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS is a medical device that received FDA 510(k) clearance on 1999-09-23. The listed applicant is Electro-Biology, Inc.. The 510(k) number is K992367.

When did EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS receive FDA 510(k) clearance?

EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS received FDA 510(k) clearance on 1999-09-23, under 510(k) number K992367.

Who is the listed applicant for EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS?

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

What is the FDA product code for EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS?

The FDA product code for EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS is HWC. This falls under the Cardiovascular category.

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 Electro-Biology, 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.

K992333EBI OMEGA 21 SYSTEMK991941EBI XFIX DFS RAIL SYSTEMK991092EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEMK990303EBI OMEGA 21 SYSTEMK990459EBI VUECATH ENDOSCOPIC SYSTENK990999MODIFICATION OF: EBI SPINELINK SYSTEM

View all 28 devices →

Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, 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.

↑