The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Summit Total Hip System.
| Device ID | K942891 |
| 510k Number | K942891 |
| Device Name: | SUMMIT TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | KIRSCHNER MEDICAL CORP. 20-01 POLLITT DR. Fair Lawn, NJ 07410 |
| Contact | Jacquelyn A Hughes |
| Correspondent | Jacquelyn A Hughes KIRSCHNER MEDICAL CORP. 20-01 POLLITT DR. Fair Lawn, NJ 07410 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-20 |
| Decision Date | 1994-11-02 |