The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Summit Acetabular System.
| Device ID | K983014 |
| 510k Number | K983014 |
| Device Name: | SUMMIT ACETABULAR SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-28 |
| Decision Date | 1998-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295218739 | K983014 | 000 |
| 10603295010425 | K983014 | 000 |
| 10603295010418 | K983014 | 000 |
| 10603295010401 | K983014 | 000 |
| 10603295010395 | K983014 | 000 |
| 10603295010388 | K983014 | 000 |
| 10603295010159 | K983014 | 000 |
| 10603295009900 | K983014 | 000 |
| 10603295009795 | K983014 | 000 |
| 10603295009306 | K983014 | 000 |
| 10603295010432 | K983014 | 000 |
| 10603295010449 | K983014 | 000 |
| 10603295010456 | K983014 | 000 |
| 10603295218722 | K983014 | 000 |
| 10603295218715 | K983014 | 000 |
| 10603295218708 | K983014 | 000 |
| 10603295218692 | K983014 | 000 |
| 10603295218685 | K983014 | 000 |
| 10603295218678 | K983014 | 000 |
| 10603295218661 | K983014 | 000 |
| 10603295218654 | K983014 | 000 |
| 10603295218647 | K983014 | 000 |
| 10603295008972 | K983014 | 000 |