The following data is part of a premarket notification filed by Joint Medical Products Corp. with the FDA for Ztt I And Ii Acetabular Cup Of The S-rom Total Hip System.
| Device ID | K951000 |
| 510k Number | K951000 |
| Device Name: | ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-03 |
| Decision Date | 1995-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295175988 | K951000 | 000 |
| 10603295170730 | K951000 | 000 |
| 10603295170723 | K951000 | 000 |
| 10603295170716 | K951000 | 000 |
| 10603295170709 | K951000 | 000 |
| 10603295170693 | K951000 | 000 |
| 10603295170686 | K951000 | 000 |
| 10603295170679 | K951000 | 000 |
| 10603295170662 | K951000 | 000 |
| 10603295170747 | K951000 | 000 |
| 10603295170754 | K951000 | 000 |
| 10603295170761 | K951000 | 000 |
| 10603295175971 | K951000 | 000 |
| 10603295175964 | K951000 | 000 |
| 10603295175957 | K951000 | 000 |
| 10603295175940 | K951000 | 000 |
| 10603295175933 | K951000 | 000 |
| 10603295175926 | K951000 | 000 |
| 10603295175919 | K951000 | 000 |
| 10603295175902 | K951000 | 000 |
| 10603295170655 | K951000 | 000 |