The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech All Poly Acetabular Cup.
| Device ID | K934253 |
| 510k Number | K934253 |
| Device Name: | EXACTECH ALL POLY ACETABULAR CUP |
| Classification | Mixer, Cement, For Clinical Use |
| 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 | JDZ |
| CFR Regulation Number | 888.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-31 |
| Decision Date | 1994-04-29 |