The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Buechel-pappas Polyethylene Glenoid Component (02-11-yyxx) Note:yy=id & Xx=od.
| Device ID | K960424 |
| 510k Number | K960424 |
| Device Name: | BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NOTE:YY=ID & XX=OD |
| Classification | Prosthesis, Shoulder, Non-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 | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-29 |
| Decision Date | 1996-08-26 |