The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Capitello-condylar Total Elbow Prosthesis.
Device ID | K983141 |
510k Number | K983141 |
Device Name: | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS |
Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
Contact | Deana Boushell |
Correspondent | Deana Boushell JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
Product Code | JDB |
CFR Regulation Number | 888.3160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-09-08 |
Decision Date | 1998-11-06 |
Summary: | summary |