Stronghold® 3D Titanium Interbody Device System SW19169-3012

GUDID 10840642161564

Lumbar Titanium Cage - Lordotic 6° 9.5 mm x 30 mm x 12 mm

Spine Wave, Inc.

Metallic spinal interbody fusion cage

Primary Device ID	10840642161564
NIH Device Record Key	44059377-627a-4bfb-bbd4-aff0acd2ad81
Commercial Distribution Status	In Commercial Distribution
Brand Name	Stronghold® 3D Titanium Interbody Device System
Version Model Number	SW19169-3012
Catalog Number	SW19169-3012
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

Customer Support Contacts

Phone	203-944-9494
Email	GUDID@spinewave.com
Phone	203-944-9494
Email	GUDID@spinewave.com
Phone	203-944-9494
Email	GUDID@spinewave.com
Phone	203-944-9494
Email	GUDID@spinewave.com
Phone	203-944-9494
Email	GUDID@spinewave.com
Phone	203-944-9494
Email	GUDID@spinewave.com
Phone	203-944-9494
Email	GUDID@spinewave.com

Device Dimensions

Width	9.5 Millimeter
Length	30 Millimeter
Height	12 Millimeter
Angle	6 degree
Width	9.5 Millimeter
Length	30 Millimeter
Height	12 Millimeter
Angle	6 degree
Width	9.5 Millimeter
Length	30 Millimeter
Height	12 Millimeter
Angle	6 degree
Width	9.5 Millimeter
Length	30 Millimeter
Height	12 Millimeter
Angle	6 degree
Width	9.5 Millimeter
Length	30 Millimeter
Height	12 Millimeter
Angle	6 degree
Width	9.5 Millimeter
Length	30 Millimeter
Height	12 Millimeter
Angle	6 degree
Width	9.5 Millimeter
Length	30 Millimeter
Height	12 Millimeter
Angle	6 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642161564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K180990

FDA Product Code

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-08-09
Device Publish Date	2021-07-30

On-Brand Devices [Stronghold® 3D Titanium Interbody Device System]

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

Trademark Results [Stronghold]

Mark Image Registration \| Serial	Company Trademark Application Date
STRONGHOLD 98313062 not registered Live/Pending	Stronghold Investment Management Holdings LP 2023-12-13
STRONGHOLD 98146643 not registered Live/Pending	Unirac, Inc. 2023-08-23
STRONGHOLD 97802042 not registered Live/Pending	Viking Products Group, Inc. 2023-02-20
STRONGHOLD 97412697 not registered Live/Pending	Panduit Corp. 2022-05-16
STRONGHOLD 97295602 not registered Live/Pending	Iron Fortress ApS 2022-03-04
STRONGHOLD 90763803 not registered Live/Pending	Lesco, Inc. 2021-06-09
STRONGHOLD 90682176 not registered Live/Pending	BPFP Holdings LLC 2021-04-29
STRONGHOLD 90590776 not registered Live/Pending	Action Factory, Inc. 2021-03-19
STRONGHOLD 90570367 not registered Live/Pending	Crosman Corporation 2021-03-10
STRONGHOLD 90380485 not registered Live/Pending	B.G.R., Inc. 2020-12-14
STRONGHOLD 88912545 not registered Live/Pending	Quanta Associates, L.P. 2020-05-12
STRONGHOLD 88749535 not registered Live/Pending	Spine Wave, Inc. 2020-01-07