The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Tri-lock Bone Preservation Stem.
| Device ID | K073570 |
| 510k Number | K073570 |
| Device Name: | DEPUY TRI-LOCK BONE PRESERVATION STEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Rhonda Myer |
| Correspondent | Rhonda Myer DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KWA |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-20 |
| Decision Date | 2008-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295033844 | K073570 | 000 |
| 10603295033486 | K073570 | 000 |
| 10603295033479 | K073570 | 000 |
| 10603295033462 | K073570 | 000 |
| 10603295033332 | K073570 | 000 |
| 10603295033325 | K073570 | 000 |
| 10603295033318 | K073570 | 000 |
| 10603295033301 | K073570 | 000 |
| 10603295000792 | K073570 | 000 |
| 10603295033653 | K073570 | 000 |
| 10603295033660 | K073570 | 000 |
| 10603295033677 | K073570 | 000 |
| 10603295033837 | K073570 | 000 |
| 10603295033820 | K073570 | 000 |
| 10603295033813 | K073570 | 000 |
| 10603295033721 | K073570 | 000 |
| 10603295033714 | K073570 | 000 |
| 10603295033707 | K073570 | 000 |
| 10603295033691 | K073570 | 000 |
| 10603295033684 | K073570 | 000 |
| 10603295000716 | K073570 | 000 |