The following data is part of a premarket notification filed by Howmedica, Pfizer Medical Technology Group with the FDA for Cdh Hip System.
| Device ID | K922008 |
| 510k Number | K922008 |
| Device Name: | CDH HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | HOWMEDICA, PFIZER MEDICAL TECHNOLOGY GROUP 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA, PFIZER MEDICAL TECHNOLOGY GROUP 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-30 |
| Decision Date | 1992-07-30 |