The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Lateral Column Length Plate, Model 824073000-3, Locked Fusion Plate, Model 824077010, Compression Fusion Plate,.
| Device ID | K091294 |
| 510k Number | K091294 |
| Device Name: | LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, |
| 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 | 2009-05-04 |
| Decision Date | 2009-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868049774 | K091294 | 000 |
| 00887868445552 | K091294 | 000 |
| 00887868445545 | K091294 | 000 |
| 00887868445538 | K091294 | 000 |
| 00887868445521 | K091294 | 000 |
| 00887868445514 | K091294 | 000 |
| 00887868532443 | K091294 | 000 |
| 00887868532412 | K091294 | 000 |
| 00887868551321 | K091294 | 000 |
| 00887868551307 | K091294 | 000 |
| 00887868551291 | K091294 | 000 |
| 00887868551284 | K091294 | 000 |
| 00887868445569 | K091294 | 000 |
| 00887868044656 | K091294 | 000 |
| 00887868049712 | K091294 | 000 |
| 00887868049705 | K091294 | 000 |
| 00887868049699 | K091294 | 000 |
| 00887868049682 | K091294 | 000 |
| 00887868048821 | K091294 | 000 |
| 00887868048814 | K091294 | 000 |
| 00887868048753 | K091294 | 000 |
| 00887868048746 | K091294 | 000 |
| 00887868048739 | K091294 | 000 |
| 00887868048722 | K091294 | 000 |
| 00887868044687 | K091294 | 000 |
| 00887868551277 | K091294 | 000 |