The following data is part of a premarket notification filed by Electro-biology, Inc. with the FDA for Ebi Xfix Dynafix System Ha Coated Screws.
| Device ID | K992367 |
| 510k Number | K992367 |
| Device Name: | EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-15 |
| Decision Date | 1999-09-23 |
| Summary: | summary |