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 |