The following data is part of a premarket notification filed by Protek, Inc. with the FDA for Arc-2f Acetabular Cup.
| Device ID | K893785 |
| 510k Number | K893785 |
| Device Name: | ARC-2F ACETABULAR CUP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| 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 | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-22 |
| Decision Date | 1989-08-09 |