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)

BIOPRO MODULAR TIBIAL TRAY

K-Number: K922841 · 1993-09-21

ApplicantBiopro, Inc.
Decision Date1993-09-21
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOPRO MODULAR TIBIAL TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Biopro, Inc.. It received FDA 510(k) clearance on 1993-09-21 under 510(k) number K922841. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPRO MODULAR TIBIAL TRAY?

BIOPRO MODULAR TIBIAL TRAY is a medical device that received FDA 510(k) clearance on 1993-09-21. The listed applicant is Biopro, Inc.. The 510(k) number is K922841.

When did BIOPRO MODULAR TIBIAL TRAY receive FDA 510(k) clearance?

BIOPRO MODULAR TIBIAL TRAY received FDA 510(k) clearance on 1993-09-21, under 510(k) number K922841.

Who is the listed applicant for BIOPRO MODULAR TIBIAL TRAY?

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

What is the FDA product code for BIOPRO MODULAR TIBIAL TRAY?

The FDA product code for BIOPRO MODULAR TIBIAL TRAY is JWH.

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 Biopro, 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.

K163627Shotel Ankle Arthrodesis Nail SystemK162674BioPro Foot Plating SystemsK132510BIOPRO - INFINITY PLATE ANCHOR SYSTEMK130298BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEMK121973BIOPRO HEMI-EDGE TOE SYSTEMK100761BIOPRO POLAR HEAD

View all 41 devices →

Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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.

↑