The following data is part of a premarket notification filed by Orthosoft Inc. (d/b/a Zimmer Cas) with the FDA for Signature One System.
| Device ID | K190595 |
| 510k Number | K190595 |
| Device Name: | Signature ONE System |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal, CA H3c 2n6 |
| Contact | Paul Hardy |
| Correspondent | Paul Hardy Orthosoft Inc. (d/b/a Zimmer CAS) 75 Queen Street Suite 3300 Montreal, CA H3c 2n6 |
| Product Code | KWT |
| Subsequent Product Code | KWS |
| Subsequent Product Code | MBF |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-07 |
| Decision Date | 2019-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024563438 | K190595 | 000 |
| 00889024647039 | K190595 | 000 |
| 00889024647046 | K190595 | 000 |
| 00889024563339 | K190595 | 000 |
| 00889024563346 | K190595 | 000 |
| 00889024563353 | K190595 | 000 |
| 00889024563360 | K190595 | 000 |
| 00889024563377 | K190595 | 000 |
| 00889024563384 | K190595 | 000 |
| 00889024563391 | K190595 | 000 |
| 00889024563407 | K190595 | 000 |
| 00889024563414 | K190595 | 000 |
| 00889024563421 | K190595 | 000 |
| 00889024585393 | K190595 | 000 |