The following data is part of a premarket notification filed by Zimmer Inc with the FDA for Cpt Hip System.
| Device ID | K191735 |
| 510k Number | K191735 |
| Device Name: | CPT Hip System |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | Zimmer Inc 1800 W Center Street Warsaw, IN 46580 |
| Contact | Caleb Barylski |
| Correspondent | Caleb Barylski Zimmer Inc 1800 W Center Street Warsaw, IN 46580 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-28 |
| Decision Date | 2020-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024145733 | K191735 | 000 |