The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Sttune (tm) Ps Knee System.
| Device ID | K111433 |
| 510k Number | K111433 |
| Device Name: | DEPUY STTUNE (TM) PS KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Nancy Friddle |
| Correspondent | Nancy Friddle DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | OIY |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-23 |
| Decision Date | 2011-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295041849 | K111433 | 000 |
| 10603295041696 | K111433 | 000 |
| 10603295041689 | K111433 | 000 |
| 10603295041672 | K111433 | 000 |
| 10603295041665 | K111433 | 000 |
| 10603295041658 | K111433 | 000 |
| 10603295041641 | K111433 | 000 |
| 10603295041634 | K111433 | 000 |
| 10603295041627 | K111433 | 000 |
| 10603295041603 | K111433 | 000 |
| 10603295041580 | K111433 | 000 |
| 10603295041856 | K111433 | 000 |
| 10603295041610 | K111433 | 000 |
| 10603295041702 | K111433 | 000 |
| 10603295041719 | K111433 | 000 |
| 10603295041832 | K111433 | 000 |
| 10603295041825 | K111433 | 000 |
| 10603295041818 | K111433 | 000 |
| 10603295041801 | K111433 | 000 |
| 10603295041795 | K111433 | 000 |
| 10603295041788 | K111433 | 000 |
| 10603295041771 | K111433 | 000 |
| 10603295041764 | K111433 | 000 |
| 10603295041757 | K111433 | 000 |
| 10603295041740 | K111433 | 000 |
| 10603295041733 | K111433 | 000 |
| 10603295041726 | K111433 | 000 |
| 10603295041597 | K111433 | 000 |