The following data is part of a premarket notification filed by Implex Corp. with the FDA for F-220 Press-fit Femoral Hip Stem System.
| Device ID | K935990 |
| 510k Number | K935990 |
| Device Name: | F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Contact | James E Malayter |
| Correspondent | James E Malayter IMPLEX CORP. 80 COMMERCE DR. Allendale, NJ 07401 -1600 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-14 |
| Decision Date | 1994-07-13 |