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)

PHOENIX BONE SCREWS PBS-TYPE SERIES

K-Number: K930125 · 1993-12-30

ApplicantPhoenix Bioengineering, Inc.
Decision Date1993-12-30
Product CodeHXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PHOENIX BONE SCREWS PBS-TYPE SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Bioengineering, Inc.. It received FDA 510(k) clearance on 1993-12-30 under 510(k) number K930125. The device is classified under product code HXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOENIX BONE SCREWS PBS-TYPE SERIES?

PHOENIX BONE SCREWS PBS-TYPE SERIES is a medical device that received FDA 510(k) clearance on 1993-12-30. The listed applicant is Phoenix Bioengineering, Inc.. The 510(k) number is K930125.

When did PHOENIX BONE SCREWS PBS-TYPE SERIES receive FDA 510(k) clearance?

PHOENIX BONE SCREWS PBS-TYPE SERIES received FDA 510(k) clearance on 1993-12-30, under 510(k) number K930125.

Who is the listed applicant for PHOENIX BONE SCREWS PBS-TYPE SERIES?

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

What is the FDA product code for PHOENIX BONE SCREWS PBS-TYPE SERIES?

The FDA product code for PHOENIX BONE SCREWS PBS-TYPE SERIES is HXA.

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 Phoenix Bioengineering, 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.

K913490PHOENIX BURR HOLE BUTTON, BURR 1K904434SEXTON CYSTOTOMY URINE PUMP (SCUP2)

Related Devices (Code: HXA)

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.

K243477Universal Tendon SpacerAskorn MedicalK000019SINGLE SIZE TENDON SPACERMedist InternationalK973385OVAL SHAPESTechnical Products, Inc.K964359AVANTA ORTHOPAEDICS TENDON SPACERAvanta Orthopaedics, Inc.K872284H-H HUNTER ACTIVE TENDON IMPLANT PCHolter-Hausner Intl.K872285H-H HUNTER ACTIVE TENDON IMPLANT DCHolter-Hausner Intl.

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.

↑