The following data is part of a premarket notification filed by Medicrea Technologies with the FDA for Impix Lumbar Interbody Device.
| Device ID | K100544 |
| 510k Number | K100544 |
| Device Name: | IMPIX LUMBAR INTERBODY DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Contact | Jd Webb |
| Correspondent | Jd Webb MEDICREA TECHNOLOGIES 1001 OAKWOOD BLVD. Round Rock, TX 78681 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2010-07-22 |
| Summary: | summary |