The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Attune Cemented Tibial Base, Fixed Bearing.
| Device ID | K170806 |
| 510k Number | K170806 |
| Device Name: | ATTUNE Cemented Tibial Base, Fixed Bearing |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | DePuy (Ireland) Loughbeg Ringaskiddy Co. Cork Munster, IE |
| Contact | Carol S. Ming |
| Correspondent | Nancy Friddle DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, IN 46582 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-17 |
| Decision Date | 2017-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295492122 | K170806 | 000 |
| 10603295492047 | K170806 | 000 |
| 10603295492054 | K170806 | 000 |
| 10603295492061 | K170806 | 000 |
| 10603295492078 | K170806 | 000 |
| 10603295492085 | K170806 | 000 |
| 10603295492092 | K170806 | 000 |
| 10603295492108 | K170806 | 000 |
| 10603295492115 | K170806 | 000 |
| 10603295492030 | K170806 | 000 |