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)

GSB ELBOW

K-Number: K901581 · 1990-10-22

ApplicantAllo Pro Corp.
Decision Date1990-10-22
Product CodeJDC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GSB ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Allo Pro Corp.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K901581. The device is classified under product code JDC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSB ELBOW?

GSB ELBOW is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Allo Pro Corp.. The 510(k) number is K901581.

When did GSB ELBOW receive FDA 510(k) clearance?

GSB ELBOW received FDA 510(k) clearance on 1990-10-22, under 510(k) number K901581.

Who is the listed applicant for GSB ELBOW?

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

What is the FDA product code for GSB ELBOW?

The FDA product code for GSB ELBOW is JDC.

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 Allo Pro Corp. 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.

K900425SURGICAL COTTON GLOVESK900392CENTERING PLUGK896669WEBER PERMALOCKK892644BIOLOX CERAMIC BALLK885049RS-CUP ACETABULAR PROSTHESISK864999KENNEDY STEM

View all 16 devices →

Related Devices (Code: JDC)

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.

K181362TEMA Elbow SystemLima Corporate S.P.A.K181307Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowZimmer, Inc.K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing CorpK123862ZIMMER NEXEL TOTAL ELBOWZimmer, Inc.K090473DISCOVERY ELBOW - X-SMALLBiomet Manufacturing CorpK060696ACCLAIM TOTAL ELBOW SYSTEMDePuy Orthopaedics, 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.

↑