The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Beuchel-pappas Glenoid Component.
| Device ID | K904879 |
| 510k Number | K904879 |
| Device Name: | BEUCHEL-PAPPAS GLENOID 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 |
|---|---|---|
| 00814193025272 | K904879 | 000 |
| 00814193025098 | K904879 | 000 |
| 00814193025081 | K904879 | 000 |
| 00814193025074 | K904879 | 000 |
| 00814193025067 | K904879 | 000 |
| 00814193025050 | K904879 | 000 |
| 00814193025043 | K904879 | 000 |
| 00814193025036 | K904879 | 000 |
| 00814193025029 | K904879 | 000 |
| 00814193025012 | K904879 | 000 |
| 00814193025005 | K904879 | 000 |
| 00814193024992 | K904879 | 000 |
| 00814193024985 | K904879 | 000 |
| 00814193024978 | K904879 | 000 |
| 00814193024961 | K904879 | 000 |
| 00814193024954 | K904879 | 000 |
| 00814193025104 | K904879 | 000 |
| 00814193025111 | K904879 | 000 |
| 00814193025265 | K904879 | 000 |
| 00814193025258 | K904879 | 000 |
| 00814193025241 | K904879 | 000 |
| 00814193025234 | K904879 | 000 |
| 00814193025227 | K904879 | 000 |
| 00814193025210 | K904879 | 000 |
| 00814193025203 | K904879 | 000 |
| 00814193025197 | K904879 | 000 |
| 00814193025180 | K904879 | 000 |
| 00814193025173 | K904879 | 000 |
| 00814193025166 | K904879 | 000 |
| 00814193025159 | K904879 | 000 |
| 00814193025142 | K904879 | 000 |
| 00814193025135 | K904879 | 000 |
| 00814193025128 | K904879 | 000 |
| 00814193024947 | K904879 | 000 |