The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Resurfacing Humeral Head System.
| Device ID | K131298 |
| 510k Number | K131298 |
| Device Name: | EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Shing Jen Tai, Phd |
| Correspondent | Shing Jen Tai, Phd EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862252340 | K131298 | 000 |
| 10885862252357 | K131298 | 000 |
| 10885862252111 | K131298 | 000 |
| 10885862252319 | K131298 | 000 |
| 10885862252302 | K131298 | 000 |
| 10885862252296 | K131298 | 000 |
| 10885862252289 | K131298 | 000 |
| 10885862252272 | K131298 | 000 |
| 10885862252265 | K131298 | 000 |
| 10885862248572 | K131298 | 000 |
| 10885862252364 | K131298 | 000 |
| 10885862252371 | K131298 | 000 |
| 10885862252388 | K131298 | 000 |
| 10885862252258 | K131298 | 000 |
| 10885862252241 | K131298 | 000 |
| 10885862252227 | K131298 | 000 |
| 10885862252210 | K131298 | 000 |
| 10885862252203 | K131298 | 000 |
| 10885862252197 | K131298 | 000 |
| 10885862252180 | K131298 | 000 |
| 10885862252401 | K131298 | 000 |
| 10885862252395 | K131298 | 000 |
| 10885862248565 | K131298 | 000 |