The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Dfs Optirom Elbow Fixator.
| Device ID | K021312 |
| 510k Number | K021312 |
| Device Name: | EBI DFS OPTIROM ELBOW FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta 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 | 2002-04-25 |
| Decision Date | 2002-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868084522 | K021312 | 000 |
| 00887868084416 | K021312 | 000 |