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 |