The following data is part of a premarket notification filed by Neosteo with the FDA for Interphalangeal Joint Fusion Device Range.
| Device ID | K191424 |
| 510k Number | K191424 |
| Device Name: | Interphalangeal Joint Fusion Device Range |
| Classification | Screw, Fixation, Bone |
| Applicant | Neosteo Malleve 2A, 1 Boulevard Jean Moulin Nantes, FR 44 100 |
| Contact | Anne-cecile Grandremy |
| Correspondent | J.d. Webb The OrthoMedix Group, Inc. 4314 W. 3800 S. West Haven, UT 84401 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-29 |
| Decision Date | 2019-08-28 |