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FDA 510(k)

RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT

K-Number: K964472 · 1997-02-03

ApplicantBiologically Oriented Prostheses
Decision Date1997-02-03
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biologically Oriented Prostheses. It received FDA 510(k) clearance on 1997-02-03 under 510(k) number K964472. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT?

RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT is a medical device that received FDA 510(k) clearance on 1997-02-03. The listed applicant is Biologically Oriented Prostheses. The 510(k) number is K964472.

When did RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT receive FDA 510(k) clearance?

RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT received FDA 510(k) clearance on 1997-02-03, under 510(k) number K964472.

Who is the listed applicant for RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT?

The FDA 510(k) record lists Biologically Oriented Prostheses as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT?

The FDA product code for RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT is KYI.

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Other records listing Biologically Oriented Prostheses 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.

K002325WUJIN #3 TIBIAL NAILK992144BIOPRO RIMMED ACETABULAR COMPOMENTK962769HORIZON HIP SYSTEMK955916TOWNLEY TOTAL ELBOW SYSTEMK954768BIOPRO HEMI-ENDO MODULAR CERAMIC HEADK952731TOWNLEY ALL POLY ACETABULAR CUP

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Related Devices (Code: KYI)

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.

K201072Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161Ensemble Orthopedics, LLCK180744Stablyx CMC Arthroplasty Implant SystemSkeletal Dynamics, LLCK111068STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5Skeletal Dynamics, LLCK112278ASCENSION NUGRIP CMC IMPLANTAscension OrthopedicK092548EXTREMITY MEDICAL TRAPEZIUM PROSTHESISExtremity Medical, LLCK061956ARTELON STT SPACERArtimplant AB

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.

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