The following data is part of a premarket notification filed by Hospital For Special Surgery with the FDA for Hss Femoral Components.
| Device ID | K934857 |
| 510k Number | K934857 |
| Device Name: | HSS FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOSPITAL FOR SPECIAL SURGERY 535 EAST 70 ST. New York, NY 10021 |
| Contact | Bruce H Robie, Ph.d |
| Correspondent | Bruce H Robie, Ph.d HOSPITAL FOR SPECIAL SURGERY 535 EAST 70 ST. New York, NY 10021 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1995-07-18 |