The following data is part of a premarket notification filed by Nlt Spine Ltd with the FDA for Prow Fusion-v.
| Device ID | K153786 |
| 510k Number | K153786 |
| Device Name: | PROW FUSION-V |
| 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, M.d., J.d. HOGAN LOVELLS US LLP 555 THRITEENTH 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 | 2015-12-31 |
| Decision Date | 2016-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981140038 | K153786 | 000 |
| 10889981139902 | K153786 | 000 |
| 10889981139896 | K153786 | 000 |
| 10889981139889 | K153786 | 000 |
| 10889981139179 | K153786 | 000 |
| 10889981139162 | K153786 | 000 |
| 10889981139155 | K153786 | 000 |
| 10889981139148 | K153786 | 000 |
| 10889981139131 | K153786 | 000 |
| 10889981139124 | K153786 | 000 |
| 10889981139117 | K153786 | 000 |
| 10889981139919 | K153786 | 000 |
| 10889981139926 | K153786 | 000 |
| 10889981140021 | K153786 | 000 |
| 10889981140014 | K153786 | 000 |
| 10889981140007 | K153786 | 000 |
| 10889981139995 | K153786 | 000 |
| 10889981139988 | K153786 | 000 |
| 10889981139971 | K153786 | 000 |
| 10889981139964 | K153786 | 000 |
| 10889981139957 | K153786 | 000 |
| 10889981139940 | K153786 | 000 |
| 10889981139933 | K153786 | 000 |
| 10889981139100 | K153786 | 000 |