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)

ENDIX RADICULAR BIOCERAMIC PIN

K-Number: K834363 · 1984-02-27

ApplicantC.B.S. Biotechnics, Inc.
Decision Date1984-02-27
Product CodeELS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDIX RADICULAR BIOCERAMIC PIN is the device name listed in this FDA 510(k) record. The listed applicant is C.B.S. Biotechnics, Inc.. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K834363. The device is classified under product code ELS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDIX RADICULAR BIOCERAMIC PIN?

ENDIX RADICULAR BIOCERAMIC PIN is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is C.B.S. Biotechnics, Inc.. The 510(k) number is K834363.

When did ENDIX RADICULAR BIOCERAMIC PIN receive FDA 510(k) clearance?

ENDIX RADICULAR BIOCERAMIC PIN received FDA 510(k) clearance on 1984-02-27, under 510(k) number K834363.

Who is the listed applicant for ENDIX RADICULAR BIOCERAMIC PIN?

The FDA 510(k) record lists C.B.S. Biotechnics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDIX RADICULAR BIOCERAMIC PIN?

The FDA product code for ENDIX RADICULAR BIOCERAMIC PIN is ELS.

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 C.B.S. Biotechnics, 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.

K834364CRYSTALLINE BONE SCREW ENDO-OSSEOUSK834361JSB JET SYRINGEK834366SURGICAL INSTRUMENTS & ACCESSORIES

Related Devices (Code: ELS)

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.

K972985SPLINT ITJeneric/Pentron, Inc.K961704MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEMDentatus USA , Ltd.K922673FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDINGGlasspan, Inc.K811209JACOB WIRZ TRANSFIXATION PINColmed, Ltd.K801525ZEST ENDODONTIC STABILIZERZest Anchors, 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.

↑