The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Altivate Anatomic To Reverse Conversion Module.
| Device ID | K173073 |
| 510k Number | K173073 |
| Device Name: | AltiVate Anatomic To Reverse Conversion Module |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| 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 | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | PAO |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190446259039 | K173073 | 000 |
| 00190446258971 | K173073 | 000 |