FDA Product Code
FDA Product Code PHM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018-05-31 | Traditional | PDF ↗ |
| K160958 | Battalion Universal Spacer System | Alphatec Spine | 2016-09-08 | Traditional | PDF ↗ |
| K150994 | NuVasive CoRoent Thoracolumbar Implants | Nu Vasive, Incorporated | 2015-06-17 | Special | PDF ↗ |
Product code PHM · Class II · Orthopedic. Data: openFDA.