The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech All Poly Acetabular Cup.
| Device ID | K963313 |
| 510k Number | K963313 |
| Device Name: | EXACTECH ALL POLY ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Contact | Martha Miller |
| Correspondent | Martha Miller EXACTECH, INC. 4613 N.W. 6TH STREET, SUITE D Gainesville, FL 32609 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-22 |
| Decision Date | 1996-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862014733 | K963313 | 000 |
| 10885862014627 | K963313 | 000 |
| 10885862014641 | K963313 | 000 |
| 10885862014757 | K963313 | 000 |
| 10885862014764 | K963313 | 000 |
| 10885862014337 | K963313 | 000 |
| 10885862014344 | K963313 | 000 |
| 10885862014351 | K963313 | 000 |
| 10885862014382 | K963313 | 000 |
| 10885862014399 | K963313 | 000 |
| 10885862014634 | K963313 | 000 |
| 10885862014658 | K963313 | 000 |
| 10885862014665 | K963313 | 000 |
| 10885862014726 | K963313 | 000 |
| 10885862014603 | K963313 | 000 |