The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Reality Long Stem Hip System.
| Device ID | K954219 |
| 510k Number | K954219 |
| Device Name: | REALITY LONG STEM HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
| Contact | Joel Slomoff |
| Correspondent | Joel Slomoff KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-08 |
| Decision Date | 1995-12-04 |