The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Tronzo Acetabular Fixation Component (1 99-02-00xx (ace. Fixation Cup) Xx=od Of Ace. Cup.
| Device ID | K963100 |
| 510k Number | K963100 |
| Device Name: | TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079 |
| Contact | Michael Pappas, Ph.d., Pe |
| Correspondent | Michael Pappas, Ph.d., Pe ENDOTEC, INC. 20 VALLEY ST. South Orange, NJ 07079 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-09 |
| Decision Date | 1997-02-12 |