The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Buechel-pappas Humeral Stem Component.
| Device ID | K904880 |
| 510k Number | K904880 |
| Device Name: | BUECHEL-PAPPAS HUMERAL STEM COMPONENT |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079 |
| Contact | Michael J Pappas |
| Correspondent | Michael J Pappas ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-30 |
| Decision Date | 1991-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814193025524 | K904880 | 000 |
| 00814193025340 | K904880 | 000 |
| 00814193025357 | K904880 | 000 |
| 00814193025364 | K904880 | 000 |
| 00814193025371 | K904880 | 000 |
| 00814193025388 | K904880 | 000 |
| 00814193025395 | K904880 | 000 |
| 00814193025401 | K904880 | 000 |
| 00814193025418 | K904880 | 000 |
| 00814193025425 | K904880 | 000 |
| 00814193025432 | K904880 | 000 |
| 00814193025487 | K904880 | 000 |
| 00814193025494 | K904880 | 000 |
| 00814193025500 | K904880 | 000 |
| 00814193025517 | K904880 | 000 |
| 00814193025333 | K904880 | 000 |