The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi, L.p.'s Line Extension To The Array Spinal System.
| Device ID | K061978 |
| 510k Number | K061978 |
| Device Name: | EBI, L.P.'S LINE EXTENSION TO THE ARRAY SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Debra Bing |
| Correspondent | Debra Bing EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-13 |
| Decision Date | 2006-08-11 |
| Summary: | summary |