The following data is part of a premarket notification filed by Nlt Spine Ltd with the FDA for Prow Fusion.
| Device ID | K151654 |
| 510k Number | K151654 |
| Device Name: | PROW FUSION |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NLT SPINE LTD 6 YAD HARUTZIM ST. Kfar-saba, IL 44641 |
| Contact | Eti Zinger |
| Correspondent | Jonathan Kahan Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-18 |
| Decision Date | 2015-07-17 |
| Summary: | summary |