The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Duracon Total Knee System Tibial Components.
| Device ID | K915512 |
| 510k Number | K915512 |
| Device Name: | DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Margaret Crowe |
| Correspondent | Margaret Crowe PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-08-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327032918 | K915512 | 000 |
| 07613327033021 | K915512 | 000 |
| 07613327033038 | K915512 | 000 |
| 07613327033045 | K915512 | 000 |
| 07613327033052 | K915512 | 000 |
| 07613327033069 | K915512 | 000 |
| 07613327033076 | K915512 | 000 |
| 07613327033083 | K915512 | 000 |
| 07613327033090 | K915512 | 000 |
| 07613327033014 | K915512 | 000 |
| 07613327033007 | K915512 | 000 |
| 07613327032925 | K915512 | 000 |
| 07613327032932 | K915512 | 000 |
| 07613327032949 | K915512 | 000 |
| 07613327032956 | K915512 | 000 |
| 07613327032963 | K915512 | 000 |
| 07613327032970 | K915512 | 000 |
| 07613327032987 | K915512 | 000 |
| 07613327032994 | K915512 | 000 |
| 07613327033106 | K915512 | 000 |
| 07613327033113 | K915512 | 000 |
| 07613327033120 | K915512 | 000 |
| 07613327033236 | K915512 | 000 |
| 07613327033243 | K915512 | 000 |
| 07613327033250 | K915512 | 000 |
| 07613327033267 | K915512 | 000 |
| 07613327033274 | K915512 | 000 |
| 07613327033281 | K915512 | 000 |
| 07613327033298 | K915512 | 000 |
| 07613327033304 | K915512 | 000 |
| 07613327033229 | K915512 | 000 |
| 07613327033212 | K915512 | 000 |
| 07613327033137 | K915512 | 000 |
| 07613327033144 | K915512 | 000 |
| 07613327033151 | K915512 | 000 |
| 07613327033168 | K915512 | 000 |
| 07613327033175 | K915512 | 000 |
| 07613327033182 | K915512 | 000 |
| 07613327033199 | K915512 | 000 |
| 07613327033205 | K915512 | 000 |
| 07613327033311 | K915512 | 000 |