The following data is part of a premarket notification filed by Stelkast Company with the FDA for Epoca Codr Stem And Head.
| Device ID | K014049 |
| 510k Number | K014049 |
| Device Name: | EPOCA CODR STEM AND HEAD |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Applicant | STELKAST COMPANY 800 VINIAL ST. #210 Pittsburgh, PA 15212 |
| Contact | Donald A Stevens |
| Correspondent | Donald A Stevens STELKAST COMPANY 800 VINIAL ST. #210 Pittsburgh, PA 15212 |
| Product Code | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-10 |
| Decision Date | 2002-01-09 |