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 |