The following data is part of a premarket notification filed by Expanding Orthopedics, Inc. with the FDA for Flxfit Intervertebral Body Fusion Device.
| Device ID | K133813 |
| 510k Number | K133813 |
| Device Name: | FLXFIT INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | EXPANDING ORTHOPEDICS, INC. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Contact | Meredith May |
| Correspondent | Meredith May EXPANDING ORTHOPEDICS, INC. 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-16 |
| Decision Date | 2014-07-15 |
| Summary: | summary |