The following data is part of a premarket notification filed by Exactech Inc with the FDA for Exactech Equinoxe Stemless Shoulder.
| Device ID | K173388 |
| 510k Number | K173388 |
| Device Name: | Exactech Equinoxe Stemless Shoulder |
| Classification | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained |
| Applicant | Exactech Inc 2320 NW 66th Court Gainesville, FL 32653 |
| Contact | Thomas Mcnamara |
| Correspondent | Thomas Mcnamara Exactech Inc 2320 NW 66th Court Gainesville, FL 32653 |
| Product Code | PKC |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-30 |
| Decision Date | 2018-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862560070 | K173388 | 000 |
| 10885862556097 | K173388 | 000 |
| 10885862602572 | K173388 | 000 |
| 10885862538789 | K173388 | 000 |
| 10885862538703 | K173388 | 000 |
| 10885862538697 | K173388 | 000 |
| 10885862538819 | K173388 | 000 |
| 10885862538802 | K173388 | 000 |
| 10885862538796 | K173388 | 000 |
| 10885862538680 | K173388 | 000 |
| 10885862538673 | K173388 | 000 |
| 10885862556103 | K173388 | 000 |
| 10885862556110 | K173388 | 000 |
| 10885862556127 | K173388 | 000 |
| 10885862560063 | K173388 | 000 |
| 10885862560056 | K173388 | 000 |
| 10885862560049 | K173388 | 000 |
| 10885862560032 | K173388 | 000 |
| 10885862560025 | K173388 | 000 |
| 10885862560001 | K173388 | 000 |
| 10885862559999 | K173388 | 000 |
| 10885862559982 | K173388 | 000 |
| 10885862556141 | K173388 | 000 |
| 10885862556134 | K173388 | 000 |
| 10885862538666 | K173388 | 000 |