The following data is part of a premarket notification filed by Nlt Spine Ltd with the FDA for Prow Fusion-l.
| Device ID | K153665 |
| 510k Number | K153665 |
| Device Name: | PROW FUSION-L |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NLT SPINE LTD 6 YAD HARUTZIM ST. Kfar-saba, IL 4464103 |
| Contact | Eti Zinger |
| Correspondent | John J Smith HOGAN LOVELLS US LLP 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-09-15 |
| Summary: | summary |