The following data is part of a premarket notification filed by Protek, Inc. with the FDA for New Jersey Femoral Hip Prosthesis For Cement Appli.
| Device ID | K884789 |
| 510k Number | K884789 |
| Device Name: | NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| 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 | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-15 |
| Decision Date | 1989-02-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814193025647 | K884789 | 000 |
| 00814193023223 | K884789 | 000 |
| 00814193023216 | K884789 | 000 |
| 00814193023209 | K884789 | 000 |
| 00814193023193 | K884789 | 000 |
| 00814193023186 | K884789 | 000 |
| 00814193023179 | K884789 | 000 |
| 00814193023162 | K884789 | 000 |
| 00814193023155 | K884789 | 000 |
| 00814193023148 | K884789 | 000 |
| 00814193023131 | K884789 | 000 |
| 00814193023124 | K884789 | 000 |
| 00814193023230 | K884789 | 000 |
| 00814193023247 | K884789 | 000 |
| 00814193023254 | K884789 | 000 |
| 00814193024831 | K884789 | 000 |
| 00814193024824 | K884789 | 000 |
| 00814193024817 | K884789 | 000 |
| 00814193024800 | K884789 | 000 |
| 00814193024794 | K884789 | 000 |
| 00814193024787 | K884789 | 000 |
| 00814193024770 | K884789 | 000 |
| 00814193024763 | K884789 | 000 |
| 00814193023285 | K884789 | 000 |
| 00814193023278 | K884789 | 000 |
| 00814193023261 | K884789 | 000 |
| 00814193023117 | K884789 | 000 |