The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zch Alpha System.
| Device ID | K954744 |
| 510k Number | K954744 |
| Device Name: | ZCH ALPHA SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Angie Ide |
| Correspondent | Angie Ide ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-16 |
| Decision Date | 1996-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024138650 | K954744 | 000 |
| 00889024138568 | K954744 | 000 |
| 00889024138575 | K954744 | 000 |
| 00889024138582 | K954744 | 000 |
| 00889024138599 | K954744 | 000 |
| 00889024138605 | K954744 | 000 |
| 00889024138612 | K954744 | 000 |
| 00889024138629 | K954744 | 000 |
| 00889024138636 | K954744 | 000 |
| 00889024138643 | K954744 | 000 |
| 00889024138551 | K954744 | 000 |