The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Platform Fracture Stem And Revision Platform Fracture Stem.
| Device ID | K092900 |
| 510k Number | K092900 |
| Device Name: | EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Tara R Patterson |
| Correspondent | Tara R Patterson EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2010-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862083760 | K092900 | 000 |
| 10885862083593 | K092900 | 000 |
| 10885862083586 | K092900 | 000 |
| 10885862083579 | K092900 | 000 |
| 10885862083562 | K092900 | 000 |
| 10885862083777 | K092900 | 000 |
| 10885862083753 | K092900 | 000 |