The following data is part of a premarket notification filed by Neosteo with the FDA for Flexitsystem Knee Osteotomy System.
| Device ID | K212545 |
| 510k Number | K212545 |
| Device Name: | FlexitSystem Knee Osteotomy System |
| Classification | Plate, Fixation, Bone |
| Applicant | Neosteo Malleve 2A, 1 Boulevard Jean Moulin Nantes, FR 44 100 |
| Contact | Jd Webb |
| Correspondent | Jd Webb The Orthomedix Group, Inc. 4314 W. 3800 S. West Haven, UT 84401 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-12 |
| Decision Date | 2022-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701173701943 | K212545 | 000 |
| 03701173701448 | K212545 | 000 |
| 03701173701462 | K212545 | 000 |
| 03701173701479 | K212545 | 000 |
| 03701173701486 | K212545 | 000 |
| 03701173701721 | K212545 | 000 |
| 03701173701745 | K212545 | 000 |
| 03701173701769 | K212545 | 000 |
| 03701173701783 | K212545 | 000 |
| 03701173701806 | K212545 | 000 |
| 03701173701820 | K212545 | 000 |
| 03701173701844 | K212545 | 000 |
| 03701173701868 | K212545 | 000 |
| 03701173701882 | K212545 | 000 |
| 03701173701905 | K212545 | 000 |
| 03701173701929 | K212545 | 000 |
| 03701173701431 | K212545 | 000 |