The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Buechel-pappas Polyethlene Acetabular Component(01-42-yyxx & 01-43-yyxx.
| Device ID | K960425 |
| 510k Number | K960425 |
| Device Name: | BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | ENDOTEC, INC. 111 ORANGE ST. Bloomfield, NJ 07003 |
| Contact | George Makris,msme |
| Correspondent | George Makris,msme ENDOTEC, INC. 111 ORANGE ST. Bloomfield, NJ 07003 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-29 |
| Decision Date | 1996-10-03 |