The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Pca Total Hip System (cementless Use).
| Device ID | K920831 |
| 510k Number | K920831 |
| Device Name: | PCA TOTAL HIP SYSTEM (CEMENTLESS USE) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Robert Smith |
| Correspondent | Robert Smith PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-20 |
| Decision Date | 1992-06-10 |