Primary Device ID | 10840642161311 |
NIH Device Record Key | 6d668136-6ad4-4d09-8d1c-c727959521ea |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Stronghold® 3D Titanium Interbody Device System |
Version Model Number | SW19109-2511 |
Catalog Number | SW19109-2511 |
Company DUNS | 067789763 |
Company Name | Spine Wave, Inc. |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 203-944-9494 |
GUDID@spinewave.com | |
Phone | 203-944-9494 |
GUDID@spinewave.com | |
Phone | 203-944-9494 |
GUDID@spinewave.com | |
Phone | 203-944-9494 |
GUDID@spinewave.com | |
Phone | 203-944-9494 |
GUDID@spinewave.com | |
Phone | 203-944-9494 |
GUDID@spinewave.com | |
Phone | 203-944-9494 |
GUDID@spinewave.com | |
Phone | 203-944-9494 |
GUDID@spinewave.com |
Width | 9.5 Millimeter |
Length | 25 Millimeter |
Height | 11 Millimeter |
Width | 9.5 Millimeter |
Length | 25 Millimeter |
Height | 11 Millimeter |
Width | 9.5 Millimeter |
Length | 25 Millimeter |
Height | 11 Millimeter |
Width | 9.5 Millimeter |
Length | 25 Millimeter |
Height | 11 Millimeter |
Width | 9.5 Millimeter |
Length | 25 Millimeter |
Height | 11 Millimeter |
Width | 9.5 Millimeter |
Length | 25 Millimeter |
Height | 11 Millimeter |
Width | 9.5 Millimeter |
Length | 25 Millimeter |
Height | 11 Millimeter |
Width | 9.5 Millimeter |
Length | 25 Millimeter |
Height | 11 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10840642161311 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-08-05 |
Device Publish Date | 2021-07-28 |
10840642161502 | Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 14 mm |
10840642161496 | Lumbar Titanium Cage – Convex 9.5 mm x 30 mm x 13 mm |
10840642161489 | Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 12 mm |
10840642161472 | Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 11 mm |
10840642161465 | Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 10 mm |
10840642161458 | Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 9 mm |
10840642161441 | Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 8 mm |
10840642161434 | Lumbar Titanium Cage - Convex 9.5 mm x 30 mm x 7 mm |
10840642161342 | Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 14 mm |
10840642161335 | Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 13 mm |
10840642161328 | Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 12 mm |
10840642161311 | Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 11 mm |
10840642161304 | Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 10 mm |
10840642161298 | Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 9 mm |
10840642161281 | Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 8 mm |
10840642161274 | Lumbar Titanium Cage - Convex 9.5 mm x 25 mm x 7 mm |
10840642161182 | Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 14 mm |
10840642161175 | Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 13 mm |
10840642161168 | Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 12 mm |
10840642161151 | Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 11 mm |
10840642161144 | Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 10 mm |
10840642161137 | Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 9 mm |
10840642161120 | Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 8 mm |
10840642161113 | Lumbar Titanium Cage - Convex 9.5 mm x 22 mm x 7 mm |
10840642161595 | Lumbar Titanium Cage - Lordotic 15° 9.5 mm x 22 mm x 7 mm |
10840642161588 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 14 mm |
10840642161571 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 13 mm |
10840642161564 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 12 mm |
10840642161557 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 11 mm |
10840642161540 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 10 mm |
10840642161533 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 9 mm |
10840642161526 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 8 mm |
10840642161519 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 7 mm |
10840642161427 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 14 mm |
10840642161410 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 13 mm |
10840642161403 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 12 mm |
10840642161397 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 11 mm |
10840642161380 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 10 mm |
10840642161373 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 9 mm |
10840642161366 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 8 mm |
10840642161359 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 25 mm x 7 mm |
10840642161267 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 14 mm |
10840642161250 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 13 mm |
10840642161243 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 12 mm |
10840642161236 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 11 mm |
10840642161229 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 10 mm |
10840642161212 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 9 mm |
10840642161205 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 8 mm |
10840642161199 | Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 22 mm x 7 mm |
10840642161748 | Lumbar Titanium Cage - Lordotic 15° 9.5 mm x 25 mm x 14 mm |