The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for S-rom(r) Ztt(tm) Acetabular Cup-apical Hole Plug.
| Device ID | K931676 |
| 510k Number | K931676 |
| Device Name: | S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Contact | Kevin J Crossen |
| Correspondent | Kevin J Crossen JOINT MEDICAL PRODUCTS CORP. 860 CANAL ST. Stamford, CT 06902 |
| Product Code | JDL |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-06 |
| Decision Date | 1994-05-18 |