The following data is part of a premarket notification filed by Neosteo with the FDA for Self- Compressive Screw.
| Device ID | K153182 |
| 510k Number | K153182 |
| Device Name: | SELF- COMPRESSIVE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | NEOSTEO 2 RUE ROBERT SCHUMAN Reze, FR 44 400 |
| Contact | Jd Webb |
| Correspondent | Jd Webb THE ORTHOMEDIX GROUP, INC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-03 |
| Decision Date | 2015-11-25 |
| Summary: | summary |