The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Microloc(tm) Porous Coated Unicondylar Knee System.
| Device ID | K880826 |
| 510k Number | K880826 |
| Device Name: | MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/composite |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KYK |
| CFR Regulation Number | 888.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-01 |
| Decision Date | 1988-03-14 |