FLXfit™
Intervertebral Fusion Device With Bone Graft, Lumbar
Expanding Orthopedics, Inc.
The following data is part of a premarket notification filed by Expanding Orthopedics, Inc. with the FDA for Flxfit™.
Pre-market Notification Details
| Device ID | K171519 |
| 510k Number | K171519 |
| Device Name: | FLXfit™ |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Expanding Orthopedics, Inc. 3379 Peachtree Road NE (Buckhead), Suite 555 Atlanta, GA 30326 |
| Contact | Ofer Bokobza |
| Correspondent | Meredith May Empirical Technologies Corp. 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 | 2017-05-24 |
| Decision Date | 2017-09-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M725AT40130 | K171519 | 000 |
| M725AT32090 | K171519 | 000 |
| M725AT32100 | K171519 | 000 |
| M725AT32110 | K171519 | 000 |
| M725AT32120 | K171519 | 000 |
| M725AT32130 | K171519 | 000 |
| M725AT40080 | K171519 | 000 |
| M725AT40090 | K171519 | 000 |
| M725AT40100 | K171519 | 000 |
| M725AT40110 | K171519 | 000 |
| M725AT40120 | K171519 | 000 |
| M725AT32080 | K171519 | 000 |
Trademark Results [FLXfit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLXFIT 86002574 4724457 Live/Registered |
Expanding Orthopedics Ltd. 2013-07-03 |
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