The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Johnson & Johnson Modular Total Knee Prosthesis.
| Device ID | K882234 |
| 510k Number | K882234 |
| Device Name: | JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-27 |
| Decision Date | 1988-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295216797 | K882234 | 000 |
| 10603295216957 | K882234 | 000 |
| 10603295216964 | K882234 | 000 |
| 10603295216971 | K882234 | 000 |
| 10603295216988 | K882234 | 000 |
| 10603295216995 | K882234 | 000 |
| 10603295217008 | K882234 | 000 |
| 10603295217015 | K882234 | 000 |
| 10603295217022 | K882234 | 000 |
| 10603295216940 | K882234 | 000 |
| 10603295216933 | K882234 | 000 |
| 10603295253105 | K882234 | 000 |
| 10603295253112 | K882234 | 000 |
| 10603295253129 | K882234 | 000 |
| 10603295253136 | K882234 | 000 |
| 10603295216896 | K882234 | 000 |
| 10603295216902 | K882234 | 000 |
| 10603295216919 | K882234 | 000 |
| 10603295216926 | K882234 | 000 |
| 10603295217039 | K882234 | 000 |
| 10603295217046 | K882234 | 000 |
| 10603295217152 | K882234 | 000 |
| 10603295217169 | K882234 | 000 |
| 10603295217176 | K882234 | 000 |
| 10603295217183 | K882234 | 000 |
| 10603295217190 | K882234 | 000 |
| 10603295217206 | K882234 | 000 |
| 10603295216773 | K882234 | 000 |
| 10603295216780 | K882234 | 000 |
| 10603295217145 | K882234 | 000 |
| 10603295217138 | K882234 | 000 |
| 10603295217053 | K882234 | 000 |
| 10603295217060 | K882234 | 000 |
| 10603295217077 | K882234 | 000 |
| 10603295217084 | K882234 | 000 |
| 10603295217091 | K882234 | 000 |
| 10603295217107 | K882234 | 000 |
| 10603295217114 | K882234 | 000 |
| 10603295217121 | K882234 | 000 |
| 10603295253099 | K882234 | 000 |