The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Posterior Stabilized Cemented Total Knee System.
| Device ID | K933494 |
| 510k Number | K933494 |
| Device Name: | EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | Timothy J Seese |
| Correspondent | Timothy J Seese EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| 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 | 1993-07-19 |
| Decision Date | 1995-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862048110 | K933494 | 000 |
| 10885862047571 | K933494 | 000 |
| 10885862047564 | K933494 | 000 |
| 10885862052674 | K933494 | 000 |
| 10885862052667 | K933494 | 000 |
| 10885862052650 | K933494 | 000 |
| 10885862052612 | K933494 | 000 |
| 10885862051998 | K933494 | 000 |
| 10885862051981 | K933494 | 000 |
| 10885862051974 | K933494 | 000 |
| 10885862051967 | K933494 | 000 |
| 10885862051950 | K933494 | 000 |
| 10885862051943 | K933494 | 000 |
| 10885862051844 | K933494 | 000 |
| 10885862051837 | K933494 | 000 |
| 10885862051820 | K933494 | 000 |
| 10885862051813 | K933494 | 000 |
| 10885862051806 | K933494 | 000 |
| 10885862047588 | K933494 | 000 |
| 10885862047595 | K933494 | 000 |
| 10885862048103 | K933494 | 000 |
| 10885862048059 | K933494 | 000 |
| 10885862048042 | K933494 | 000 |
| 10885862048035 | K933494 | 000 |
| 10885862048011 | K933494 | 000 |
| 10885862048004 | K933494 | 000 |
| 10885862047991 | K933494 | 000 |
| 10885862047960 | K933494 | 000 |
| 10885862047953 | K933494 | 000 |
| 10885862047946 | K933494 | 000 |
| 10885862047908 | K933494 | 000 |
| 10885862047892 | K933494 | 000 |
| 10885862047885 | K933494 | 000 |
| 10885862047847 | K933494 | 000 |
| 10885862047830 | K933494 | 000 |
| 10885862047823 | K933494 | 000 |
| 10885862047601 | K933494 | 000 |
| 10885862051790 | K933494 | 000 |