The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Xfix Dfs Rail System.
| Device ID | K991941 |
| 510k Number | K991941 |
| Device Name: | EBI XFIX DFS RAIL SYSTEM |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ELECTRO-BIOLOGY, INC. 100 INTERPACE PKWY. Parsippany, NJ 07054 |
| Contact | Jonas Wilf |
| Correspondent | Jonas Wilf ELECTRO-BIOLOGY, INC. 100 INTERPACE PKWY. 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 | 1999-06-09 |
| Decision Date | 1999-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868357794 | K991941 | 000 |
| 00887868083600 | K991941 | 000 |
| 00887868083648 | K991941 | 000 |
| 00887868083655 | K991941 | 000 |
| 00887868083747 | K991941 | 000 |
| 00887868083761 | K991941 | 000 |
| 00887868083815 | K991941 | 000 |
| 00887868083822 | K991941 | 000 |
| 00887868083877 | K991941 | 000 |
| 00887868083884 | K991941 | 000 |
| 00887868083891 | K991941 | 000 |
| 00887868083921 | K991941 | 000 |
| 00887868084010 | K991941 | 000 |
| 00887868084027 | K991941 | 000 |
| 00888480111160 | K991941 | 000 |
| 00888480112570 | K991941 | 000 |
| 00887868083594 | K991941 | 000 |