The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom Zt Ha Proximal Femoral Sleeve.
| Device ID | K912713 |
| 510k Number | K912713 |
| Device Name: | S-ROM ZT HA PROXIMAL FEMORAL SLEEVE |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Contact | Debra Bing |
| Correspondent | Debra Bing JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| 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 | 1991-06-20 |
| Decision Date | 1991-12-30 |