KHEIRON® Spinal Fixation System
Thoracolumbosacral Pedicle Screw System
S.M.A.I.O.
The following data is part of a premarket notification filed by S.m.a.i.o. with the FDA for Kheiron® Spinal Fixation System.
Pre-market Notification Details
| Device ID | K211981 |
| 510k Number | K211981 |
| Device Name: | KHEIRON® Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | S.M.A.I.O. 2, Place Berthe Morisot Parc Technologique Saint-Priest, FR 69800 |
| Contact | Jean-Charles Roussouly |
| Correspondent | J.D. Webb The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, UT 84401 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-25 |
| Decision Date | 2022-06-09 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701313005047 | K211981 | 000 |
| 03701313005030 | K211981 | 000 |
Trademark Results [KHEIRON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KHEIRON 79165301 4872495 Live/Registered |
S.M.A.I.O 2015-03-12 |
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