The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Altivate Reverse Humeral Stem, 48mm.
| Device ID | K190290 |
| 510k Number | K190290 |
| Device Name: | AltiVate Reverse Humeral Stem, 48mm |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| 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 | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-11 |
| Decision Date | 2019-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446334989 | K190290 | 000 |
| 00190446334880 | K190290 | 000 |
| 00190446334897 | K190290 | 000 |
| 00190446334903 | K190290 | 000 |
| 00190446334910 | K190290 | 000 |
| 00190446334927 | K190290 | 000 |
| 00190446334934 | K190290 | 000 |
| 00190446334941 | K190290 | 000 |
| 00190446334958 | K190290 | 000 |
| 00190446334965 | K190290 | 000 |
| 00190446334972 | K190290 | 000 |
| 00190446335672 | K190290 | 000 |