The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Cruciate Retaining Cemented Tibial Components.
| Device ID | K932776 |
| 510k Number | K932776 |
| Device Name: | CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS |
| 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 | 1993-06-08 |
| Decision Date | 1994-10-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862039828 | K932776 | 000 |
| 10885862002785 | K932776 | 000 |
| 10885862002778 | K932776 | 000 |
| 10885862002761 | K932776 | 000 |
| 10885862002754 | K932776 | 000 |
| 10885862002747 | K932776 | 000 |
| 10885862002730 | K932776 | 000 |
| 10885862002723 | K932776 | 000 |
| 10885862002686 | K932776 | 000 |
| 10885862002679 | K932776 | 000 |
| 10885862002662 | K932776 | 000 |
| 10885862002624 | K932776 | 000 |
| 10885862002617 | K932776 | 000 |
| 10885862002792 | K932776 | 000 |
| 10885862039699 | K932776 | 000 |
| 10885862039811 | K932776 | 000 |
| 10885862039804 | K932776 | 000 |
| 10885862039798 | K932776 | 000 |
| 10885862039781 | K932776 | 000 |
| 10885862039774 | K932776 | 000 |
| 10885862039767 | K932776 | 000 |
| 10885862039750 | K932776 | 000 |
| 10885862039743 | K932776 | 000 |
| 10885862039736 | K932776 | 000 |
| 10885862039729 | K932776 | 000 |
| 10885862039712 | K932776 | 000 |
| 10885862039705 | K932776 | 000 |
| 10885862002600 | K932776 | 000 |