The following data is part of a premarket notification filed by Protek, Inc. with the FDA for Freeman-samuelson Mark Ii Press-fit Total Knee Rep.
| Device ID | K853730 |
| 510k Number | K853730 |
| Device Name: | FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uhmwpe, Pegged, Cemented, Polymer/metal/polymer |
| 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 | MBV |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-06 |
| Decision Date | 1986-02-18 |