The following data is part of a premarket notification filed by Nexa Orthopedics, Inc. with the FDA for Nexa Bone Screw System.
| Device ID | K053394 |
| 510k Number | K053394 |
| Device Name: | NEXA BONE SCREW SYSTEM |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-06 |
| Decision Date | 2005-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889797099332 | K053394 | 000 |
| 00889797099325 | K053394 | 000 |
| 00889797099318 | K053394 | 000 |
| 00889797099301 | K053394 | 000 |
| 00889797099295 | K053394 | 000 |
| 00889797099288 | K053394 | 000 |