The following data is part of a premarket notification filed by Encore Medical, L.p with the FDA for Altivate Anatomic Canal-sparing (cs) Shoulder.
| Device ID | K193226 |
| 510k Number | K193226 |
| Device Name: | AltiVate Anatomic Canal-Sparing (CS) Shoulder |
| Classification | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained |
| Applicant | Encore Medical, L.P 9800 Metric Blvd Austin, TX 78758 |
| Contact | Teffany Hutto |
| Correspondent | Teffany Hutto Encore Medical, L.P 9800 Metric Blvd Austin, TX 78758 |
| Product Code | PKC |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-22 |
| Decision Date | 2020-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446648949 | K193226 | 000 |
| 00190446648598 | K193226 | 000 |
| 00190446648581 | K193226 | 000 |
| 00190446648574 | K193226 | 000 |
| 00190446648567 | K193226 | 000 |
| 00190446648550 | K193226 | 000 |
| 00190446648543 | K193226 | 000 |
| 00190446648499 | K193226 | 000 |
| 00190446648482 | K193226 | 000 |
| 00190446648413 | K193226 | 000 |
| 00190446648406 | K193226 | 000 |
| 00190446648390 | K193226 | 000 |
| 00190446648321 | K193226 | 000 |
| 00190446648314 | K193226 | 000 |
| 00190446648307 | K193226 | 000 |
| 00190446648604 | K193226 | 000 |
| 00190446648338 | K193226 | 000 |
| 00190446648345 | K193226 | 000 |
| 00190446648659 | K193226 | 000 |
| 00190446648642 | K193226 | 000 |
| 00190446648635 | K193226 | 000 |
| 00190446647898 | K193226 | 000 |
| 00190446648611 | K193226 | 000 |
| 00190446648475 | K193226 | 000 |
| 00190446648468 | K193226 | 000 |
| 00190446648451 | K193226 | 000 |
| 00190446648444 | K193226 | 000 |
| 00190446648437 | K193226 | 000 |
| 00190446648420 | K193226 | 000 |
| 00190446648383 | K193226 | 000 |
| 00190446648376 | K193226 | 000 |
| 00190446648369 | K193226 | 000 |
| 00190446647881 | K193226 | 000 |