The following data is part of a premarket notification filed by Protek, Inc. with the FDA for Modified Protasul 100 (ti-6a1-7nb) Alloy.
Device ID | K861988 |
510k Number | K861988 |
Device Name: | MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278 |
Contact | Kenneth Epling |
Correspondent | Kenneth Epling PROTEK, INC. 5780 WEST 71ST ST. Indianapolis, IN 46278 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-09 |
Decision Date | 1987-02-11 |