The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Nexa Bone Plate And Screw System.
| Device ID | K053408 |
| 510k Number | K053408 |
| Device Name: | NEXA BONE PLATE AND SCREW SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | NEXA ORTHOPEDICS, INC. 10675 SORRENTO VALLEY ROAD SUITE 100 San Diego, CA 92121 |
| Contact | Louise M Focht |
| Correspondent | Louise M Focht NEXA ORTHOPEDICS, INC. 10675 SORRENTO VALLEY ROAD SUITE 100 San Diego, CA 92121 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-07 |
| Decision Date | 2005-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832006922 | K053408 | 000 |
| 00846832006779 | K053408 | 000 |
| 00846832006762 | K053408 | 000 |
| 00846832006755 | K053408 | 000 |
| 00846832006748 | K053408 | 000 |
| 00846832006731 | K053408 | 000 |
| 00846832006724 | K053408 | 000 |
| 00846832006717 | K053408 | 000 |
| 00846832006700 | K053408 | 000 |
| 00846832006786 | K053408 | 000 |
| 00846832006793 | K053408 | 000 |
| 00846832006915 | K053408 | 000 |
| 00846832006908 | K053408 | 000 |
| 00846832006892 | K053408 | 000 |
| 00846832006885 | K053408 | 000 |
| 00846832006878 | K053408 | 000 |
| 00846832006861 | K053408 | 000 |
| 00846832006854 | K053408 | 000 |
| 00846832006809 | K053408 | 000 |
| 00846832006694 | K053408 | 000 |