The following data is part of a premarket notification filed by Protek, Inc. with the FDA for Muller Self Locking Total Hip.
| Device ID | K853768 |
| 510k Number | K853768 |
| Device Name: | MULLER SELF LOCKING TOTAL HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | PROTEK, INC. ONE PARK FLETCHER 2601 FORTUNE CIR. E. STE.105B Indianapolis, IN 46241 |
| Contact | Kenneth Epling |
| Correspondent | Kenneth Epling PROTEK, INC. ONE PARK FLETCHER 2601 FORTUNE CIR. E. STE.105B Indianapolis, IN 46241 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-09 |
| Decision Date | 1985-11-19 |