The following data is part of a premarket notification filed by Medicrea Technologies with the FDA for Impix Alif Lumbar Ibf, Impix Alif-d Lumbar Ibf, Impix Tlif Lumbar Ibf.
| Device ID | K083798 |
| 510k Number | K083798 |
| Device Name: | IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDICREA TECHNOLOGIES 111 HILL ROAD Douglassville, PA 19518 |
| Contact | Donald Guthner |
| Correspondent | Donald Guthner MEDICREA TECHNOLOGIES 111 HILL ROAD Douglassville, PA 19518 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2010-05-19 |
| Summary: | summary |