The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Acumatch L-series Unipolar Endoprosthesis.
| Device ID | K010081 |
| 510k Number | K010081 |
| Device Name: | ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Lisa Simpson |
| Correspondent | Lisa Simpson 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 | 2001-01-10 |
| Decision Date | 2001-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862012074 | K010081 | 000 |
| 10885862011947 | K010081 | 000 |
| 10885862011930 | K010081 | 000 |
| 10885862011923 | K010081 | 000 |
| 10885862011916 | K010081 | 000 |
| 10885862011909 | K010081 | 000 |
| 10885862011893 | K010081 | 000 |
| 10885862011886 | K010081 | 000 |
| 10885862011879 | K010081 | 000 |
| 10885862011862 | K010081 | 000 |
| 10885862011855 | K010081 | 000 |
| 10885862011954 | K010081 | 000 |
| 10885862011961 | K010081 | 000 |
| 10885862012067 | K010081 | 000 |
| 10885862012050 | K010081 | 000 |
| 10885862012043 | K010081 | 000 |
| 10885862012036 | K010081 | 000 |
| 10885862012029 | K010081 | 000 |
| 10885862012012 | K010081 | 000 |
| 10885862012005 | K010081 | 000 |
| 10885862011992 | K010081 | 000 |
| 10885862011985 | K010081 | 000 |
| 10885862011978 | K010081 | 000 |
| 10885862012180 | K010081 | 000 |