The following data is part of a premarket notification filed by Allo Pro Corp. with the FDA for Kennedy Stem.
| Device ID | K864999 |
| 510k Number | K864999 |
| Device Name: | KENNEDY STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
| Contact | Sylvia Pierpoint |
| Correspondent | Sylvia Pierpoint ALLO PRO CORP. POST OFFICE BOX 14159 Clearwater, FL 34279 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-09-09 |