The following data is part of a premarket notification filed by Etex Corp. with the FDA for Etex Ha Hip Replacement System.
| Device ID | K935696 |
| 510k Number | K935696 |
| Device Name: | ETEX HA HIP REPLACEMENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139 |
| Contact | Dosuk D Lee |
| Correspondent | Dosuk D Lee ETEX CORP. 38 SIDNEY ST., 3FLR THE CLARK BLDG. Cambridge, MA 02139 |
| 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 | 1993-11-30 |
| Decision Date | 1994-07-22 |