The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Xfix Dfs Optirom Elbow Fixator.
| Device ID | K992515 |
| 510k Number | K992515 |
| Device Name: | EBI XFIX DFS OPTIROM ELBOW FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Jonas Wilf |
| Correspondent | Jonas Wilf EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-28 |
| Decision Date | 1999-08-17 |
| Summary: | summary |