The following data is part of a premarket notification filed by Nlt Spine Ltd with the FDA for Prow Fusion.
| Device ID | K130254 |
| 510k Number | K130254 |
| Device Name: | PROW FUSION |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NLT SPINE LTD 555 THIRTEENTH STREET NW Washington, DC 20004 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan NLT SPINE LTD 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 | 2013-02-01 |
| Decision Date | 2013-10-16 |
| Summary: | summary |