The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Dynafix Vs Osteotomy System.
| Device ID | K010551 |
| 510k Number | K010551 |
| Device Name: | EBI DYNAFIX VS OSTEOTOMY SYSTEM |
| Classification | Plate, Fixation, Bone, Non-spinal, Metallic |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Patricia Flood |
| Correspondent | Patricia Flood EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | NDF |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-26 |
| Decision Date | 2001-05-17 |