The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Buechel-pappas Modular Salvage Stem.
| Device ID | K982418 |
| 510k Number | K982418 |
| Device Name: | BUECHEL-PAPPAS MODULAR SALVAGE STEM |
| Classification | Prosthesis, Shoulder, Humeral (bipolar Hemi-shoulder) Metal/polymer, Cemented Or Uncemented |
| Applicant | ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079 |
| Contact | George Makris |
| Correspondent | George Makris ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079 |
| Product Code | MJT |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1999-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814193025562 | K982418 | 000 |
| 00814193025555 | K982418 | 000 |
| 00814193025548 | K982418 | 000 |
| 00814193025531 | K982418 | 000 |
| 00814193025470 | K982418 | 000 |
| 00814193025463 | K982418 | 000 |
| 00814193025456 | K982418 | 000 |
| 00814193025449 | K982418 | 000 |