The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Esl Spine Spacer System.
| Device ID | K040482 |
| 510k Number | K040482 |
| Device Name: | EBI ESL SPINE SPACER SYSTEM |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Frederic Testa |
| Correspondent | Frederic Testa EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-25 |
| Decision Date | 2004-04-16 |
| Summary: | summary |