The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom Zirconia Cermamic Femoral Head.
| Device ID | K921111 |
| 510k Number | K921111 |
| Device Name: | S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Contact | Debra L Bing |
| Correspondent | Debra L Bing JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1992-10-22 |