Primary Device ID | 00814216023667 |
NIH Device Record Key | b9cfe942-2fb1-4876-b48f-71d4c38b2883 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PLIF FortiCore |
Version Model Number | 10499-0003 |
Catalog Number | 10499-0003 |
Company DUNS | 079898044 |
Company Name | NANOVIS SPINE, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 8779076266 |
nanovisquality@nanovistechnology.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00814216023667 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00814216023667]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2019-04-22 |
00814216029973 - Anatomic PEEK™ Cervical Fusion System with Nanotechnology | 2023-10-04 Anatomic Cervical 10° Trial Case |
00814216026439 - Anatomic PEEK™ Cervical Fusion System with Nanotechnology | 2023-10-03 Anatomic PEEK Trial, 5 x 14 x 11 x 10° |
00814216026446 - Anatomic PEEK™ Cervical Fusion System with Nanotechnology | 2023-10-03 Anatomic PEEK Trial, 6 x 14 x 11 x 10° |
00814216026453 - Anatomic PEEK™ Cervical Fusion System with Nanotechnology | 2023-10-03 Anatomic PEEK Trial, 7 x 14 x 11 x 10° |
00814216026460 - Anatomic PEEK™ Cervical Fusion System with Nanotechnology | 2023-10-03 Anatomic PEEK Trial, 8 x 14 x 11 x 10° |
00814216026477 - Anatomic PEEK™ Cervical Fusion System with Nanotechnology | 2023-10-03 Anatomic PEEK Trial, 9 x 14 x 11 x 10° |
00814216026484 - Anatomic PEEK™ Cervical Fusion System with Nanotechnology | 2023-10-03 Anatomic PEEK Trial, 10 x 14 x 11 x 10° |
00814216026491 - Anatomic PEEK™ Cervical Fusion System with Nanotechnology | 2023-10-03 Anatomic PEEK Trial, 5 x 16 x 14 x 10° |