The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Closed Fusion Plate, Mtp Plate, Talus Plate, Model 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467.
| Device ID | K101240 |
| 510k Number | K101240 |
| Device Name: | CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 |
| Classification | Plate, Fixation, Bone |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Suzana Otano |
| Correspondent | Suzana Otano DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-04 |
| Decision Date | 2010-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868049798 | K101240 | 000 |
| 00887868445507 | K101240 | 000 |
| 00887868445491 | K101240 | 000 |
| 00887868445484 | K101240 | 000 |
| 00887868445477 | K101240 | 000 |
| 00887868532511 | K101240 | 000 |
| 00887868532504 | K101240 | 000 |
| 00887868532474 | K101240 | 000 |
| 00887868551239 | K101240 | 000 |
| 00887868445675 | K101240 | 000 |
| 00887868048685 | K101240 | 000 |
| 00887868049781 | K101240 | 000 |
| 00887868049743 | K101240 | 000 |
| 00887868049651 | K101240 | 000 |
| 00887868049644 | K101240 | 000 |
| 00887868048845 | K101240 | 000 |
| 00887868048838 | K101240 | 000 |
| 00887868048784 | K101240 | 000 |
| 00887868048692 | K101240 | 000 |
| 00887868551215 | K101240 | 000 |