The following data is part of a premarket notification filed by Protek, Inc. with the FDA for Modified New Jersey Acetabular Comp. & Bone Screws.
| Device ID | K884888 |
| 510k Number | K884888 |
| Device Name: | MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS |
| 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-22 |
| Decision Date | 1988-12-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814193025630 | K884888 | 000 |
| 00814193025623 | K884888 | 000 |
| 00814193025616 | K884888 | 000 |
| 00814193025609 | K884888 | 000 |
| 00814193025593 | K884888 | 000 |