The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Memory Staple.
| Device ID | K060746 |
| 510k Number | K060746 |
| Device Name: | MEMORY STAPLE |
| Classification | Staple, Fixation, Bone |
| 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 | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-20 |
| Decision Date | 2006-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868129551 | K060746 | 000 |
| 00887868117701 | K060746 | 000 |
| 00887868117695 | K060746 | 000 |
| 00887868117688 | K060746 | 000 |
| 00887868117664 | K060746 | 000 |
| 00887868117657 | K060746 | 000 |
| 08426750031361 | K060746 | 000 |
| 08426750031354 | K060746 | 000 |
| 08426750031347 | K060746 | 000 |
| 08426750031330 | K060746 | 000 |
| 00887868117718 | K060746 | 000 |
| 00887868117725 | K060746 | 000 |
| 00887868117862 | K060746 | 000 |
| 00887868117855 | K060746 | 000 |
| 00887868117848 | K060746 | 000 |
| 00887868117831 | K060746 | 000 |
| 00887868117824 | K060746 | 000 |
| 00887868117800 | K060746 | 000 |
| 00887868117756 | K060746 | 000 |
| 00887868117749 | K060746 | 000 |
| 00887868117732 | K060746 | 000 |
| 08426750031323 | K060746 | 000 |