The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Acumatch A-series Corundum Acetabular Component And Acumatch A-series Corundum Acetabular Component With Hydroxyapatite.
| Device ID | K000242 |
| 510k Number | K000242 |
| Device Name: | ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Gary J Miller |
| Correspondent | Gary J Miller EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-27 |
| Decision Date | 2000-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862021885 | K000242 | 000 |
| 10885862021762 | K000242 | 000 |
| 10885862021779 | K000242 | 000 |
| 10885862021786 | K000242 | 000 |
| 10885862021793 | K000242 | 000 |
| 10885862021809 | K000242 | 000 |
| 10885862021816 | K000242 | 000 |
| 10885862021823 | K000242 | 000 |
| 10885862021830 | K000242 | 000 |
| 10885862021847 | K000242 | 000 |
| 10885862021854 | K000242 | 000 |
| 10885862021861 | K000242 | 000 |
| 10885862021878 | K000242 | 000 |
| 10885862021755 | K000242 | 000 |