The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom Oblong Acetabular Cup.
Device ID | K905258 |
510k Number | K905258 |
Device Name: | S-ROM OBLONG ACETABULAR CUP |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
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 | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-21 |
Decision Date | 1991-05-21 |