The following data is part of a premarket notification filed by Ebi, Llc with the FDA for Construx External Fixation Device.
| Device ID | K111376 |
| 510k Number | K111376 |
| Device Name: | CONSTRUX EXTERNAL FIXATION DEVICE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EBI, LLC 399 Jefferson Rd Parsippany, NJ 07054 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe EBI, LLC 399 Jefferson Rd Parsippany, NJ 07054 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-16 |
| Decision Date | 2011-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868099786 | K111376 | 000 |
| 00887868099700 | K111376 | 000 |
| 00887868099717 | K111376 | 000 |
| 00887868099724 | K111376 | 000 |
| 00887868099731 | K111376 | 000 |
| 00887868099748 | K111376 | 000 |
| 00887868099755 | K111376 | 000 |
| 00887868099762 | K111376 | 000 |
| 00887868099779 | K111376 | 000 |
| 00887868099656 | K111376 | 000 |