The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Posterior Lateral Plates.
| Device ID | K103408 |
| 510k Number | K103408 |
| Device Name: | POSTERIOR LATERAL PLATES |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-19 |
| Decision Date | 2010-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868130212 | K103408 | 000 |
| 00887868532207 | K103408 | 000 |
| 00887868532214 | K103408 | 000 |
| 00887868532221 | K103408 | 000 |
| 00887868436178 | K103408 | 000 |
| 00887868436185 | K103408 | 000 |
| 00887868436192 | K103408 | 000 |
| 00887868436208 | K103408 | 000 |
| 00887868013225 | K103408 | 000 |
| 00887868013232 | K103408 | 000 |
| 00887868013249 | K103408 | 000 |
| 00887868013256 | K103408 | 000 |
| 00887868130182 | K103408 | 000 |
| 00887868130199 | K103408 | 000 |
| 00887868130205 | K103408 | 000 |
| 00887868532191 | K103408 | 000 |