The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Shoulder Stems.
| Device ID | K061454 |
| 510k Number | K061454 |
| Device Name: | EXACTECH EQUINOXE SHOULDER STEMS |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Maritza Elias |
| Correspondent | Maritza Elias EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-25 |
| Decision Date | 2006-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862530479 | K061454 | 000 |
| 10885862530462 | K061454 | 000 |
| 10885862580108 | K061454 | 000 |
| 10885862573704 | K061454 | 000 |
| 10885862557841 | K061454 | 000 |
| 10885862080073 | K061454 | 000 |
| 10885862080066 | K061454 | 000 |