The following data is part of a premarket notification filed by Premia Spine, Ltd. with the FDA for Premia Spine Xl Instruments.
| Device ID | K191854 |
| 510k Number | K191854 |
| Device Name: | Premia Spine XL Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Premia Spine, Ltd. 7 Giborey Israel Street Ramat Poleg, IL 42504 |
| Contact | Ron Sacher |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, PA 19103 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-10 |
| Decision Date | 2019-10-08 |
| Summary: | summary |