The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi X Fix Dynafix System/ebi Dfs Distal Radius Fixator Sc Bone Screws.
| Device ID | K961433 |
| 510k Number | K961433 |
| Device Name: | EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Contact | Sharon A Starowicz |
| Correspondent | Sharon A Starowicz ELECTRO-BIOLOGY, INC. 6 UPPER POND RD. P.O. BOX 345 Parsippany, NJ 07054 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-15 |
| Decision Date | 1996-06-28 |
| Summary: | summary |