The following data is part of a premarket notification filed by Protek, Inc. with the FDA for Femoral Heads/modular & Fixed W/ Titan Nitride Sur.
| Device ID | K892059 |
| 510k Number | K892059 |
| Device Name: | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal Ball |
| 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 | LZY |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-29 |
| Decision Date | 1989-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814193024930 | K892059 | 000 |
| 00814193023773 | K892059 | 000 |
| 00814193023766 | K892059 | 000 |
| 00814193023759 | K892059 | 000 |
| 00814193023742 | K892059 | 000 |
| 00814193023735 | K892059 | 000 |
| 00814193023728 | K892059 | 000 |
| 00814193023711 | K892059 | 000 |
| 00814193023704 | K892059 | 000 |
| 00814193023780 | K892059 | 000 |
| 00814193024848 | K892059 | 000 |
| 00814193024923 | K892059 | 000 |
| 00814193024916 | K892059 | 000 |
| 00814193024909 | K892059 | 000 |
| 00814193024893 | K892059 | 000 |
| 00814193024886 | K892059 | 000 |
| 00814193024879 | K892059 | 000 |
| 00814193024862 | K892059 | 000 |
| 00814193024855 | K892059 | 000 |
| 00814193023698 | K892059 | 000 |