The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for G2 Total Hip System Femoral Stem (11/13 Taper).
| Device ID | K982812 |
| 510k Number | K982812 |
| Device Name: | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Mary E Gray |
| Correspondent | Mary E Gray JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | KWY |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-11 |
| Decision Date | 1998-12-04 |
| Summary: | summary |