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FDA 510(k)

CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

K-Number: K983141 · 1998-11-06

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1998-11-06
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1998-11-06 under 510(k) number K983141. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS?

CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS is a medical device that received FDA 510(k) clearance on 1998-11-06. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K983141.

When did CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS receive FDA 510(k) clearance?

CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS received FDA 510(k) clearance on 1998-11-06, under 510(k) number K983141.

Who is the listed applicant for CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS?

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

What is the FDA product code for CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS?

The FDA product code for CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS is JDB.

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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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