The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Modification To: Acumatch L-series Bipolar Endoprosthesis.
| Device ID | K013211 |
| 510k Number | K013211 |
| Device Name: | MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Robert Paxson |
| Correspondent | Robert Paxson EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-26 |
| Decision Date | 2001-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862009555 | K013211 | 000 |
| 10885862009418 | K013211 | 000 |
| 10885862009401 | K013211 | 000 |
| 10885862009395 | K013211 | 000 |
| 10885862009388 | K013211 | 000 |
| 10885862009371 | K013211 | 000 |
| 10885862009357 | K013211 | 000 |
| 10885862009340 | K013211 | 000 |
| 10885862009333 | K013211 | 000 |
| 10885862009326 | K013211 | 000 |
| 10885862009319 | K013211 | 000 |
| 10885862009425 | K013211 | 000 |
| 10885862009432 | K013211 | 000 |
| 10885862009449 | K013211 | 000 |
| 10885862009548 | K013211 | 000 |
| 10885862009531 | K013211 | 000 |
| 10885862009524 | K013211 | 000 |
| 10885862009517 | K013211 | 000 |
| 10885862009500 | K013211 | 000 |
| 10885862009494 | K013211 | 000 |
| 10885862009487 | K013211 | 000 |
| 10885862009470 | K013211 | 000 |
| 10885862009463 | K013211 | 000 |
| 10885862009456 | K013211 | 000 |
| 10885862009302 | K013211 | 000 |