The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Duracon Modular Femoral Component And Femoral Spac.
| Device ID | K920034 |
| 510k Number | K920034 |
| Device Name: | DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-06 |
| Decision Date | 1992-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327048872 | K920034 | 000 |