Primary Device ID | 10840642162059 |
NIH Device Record Key | b804af5b-df72-4d74-a878-a1dd0a44d6ec |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Stronghold® T 3D Titanium Interbody Device System |
Version Model Number | SW19106-3010 |
Catalog Number | SW19106-3010 |
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 |
Length | 30 Millimeter |
Height | 10 Millimeter |
Angle | 6 degree |
Length | 30 Millimeter |
Height | 10 Millimeter |
Angle | 6 degree |
Length | 30 Millimeter |
Height | 10 Millimeter |
Angle | 6 degree |
Length | 30 Millimeter |
Height | 10 Millimeter |
Angle | 6 degree |
Length | 30 Millimeter |
Height | 10 Millimeter |
Angle | 6 degree |
Length | 30 Millimeter |
Height | 10 Millimeter |
Angle | 6 degree |
Length | 30 Millimeter |
Height | 10 Millimeter |
Angle | 6 degree |
Length | 30 Millimeter |
Height | 10 Millimeter |
Angle | 6 degree |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10840642162059 [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 |
10840642162110 | Curved Titanium Cage - Lordotic 30 mm x 16 mm |
10840642162103 | Curved Titanium Cage - Lordotic 30 mm x 15 mm |
10840642162097 | Curved Titanium Cage - Lordotic 30 mm x 14 mm |
10840642162080 | Curved Titanium Cage - Lordotic 30 mm x 13 mm |
10840642162073 | Curved Titanium Cage - Lordotic 30 mm x 12 mm |
10840642162066 | Curved Titanium Cage - Lordotic 30 mm x 11 mm |
10840642162059 | Curved Titanium Cage - Lordotic 30 mm x 10 mm |
10840642162042 | Curved Titanium Cage - Lordotic 30 mm x 9 mm |
10840642162035 | Curved Titanium Cage - Lordotic 30 mm x 8 mm |