Stabilis

GUDID 00810161110438

Stabilis NF Ti Cervical Interbody 14x12x9 5°, STERILE

ACUITY SURGICAL DEVICES, LLC

Metallic spinal interbody fusion cage

Primary Device ID	00810161110438
NIH Device Record Key	34d1364f-3d7c-4455-9b05-4c84fdaccb16
Commercial Distribution Status	In Commercial Distribution
Brand Name	Stabilis
Version Model Number	30-14120905-SP
Company DUNS	025855111
Company Name	ACUITY SURGICAL DEVICES, LLC
Device Count	1
DM Exempt	true
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	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com
Phone	8442284890
Email	support@acuitysurgical.com

Device Dimensions

Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree
Length	14 Millimeter
Width	12 Millimeter
Height	9 Millimeter
Angle	5 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810161110438 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K230639

FDA Product Code

ODP	Intervertebral Fusion Device With Bone Graft, Cervical

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	2024-07-15
Device Publish Date	2024-07-06

On-Brand Devices [Stabilis]

00810161110759	Stabilis NF Ti Cervical Interbody 16x14x12 15°, STERILE
00810161110742	Stabilis NF Ti Cervical Interbody 16x14x12 10°, STERILE
00810161110735	Stabilis NF Ti Cervical Interbody 16x14x12 5°, STERILE
00810161110728	Stabilis NF Ti Cervical Interbody 16x14x11 15°, STERILE
00810161110711	Stabilis NF Ti Cervical Interbody 16x14x11 10°, STERILE
00810161110704	Stabilis NF Ti Cervical Interbody 16x14x11 5°, STERILE
00810161110698	Stabilis NF Ti Cervical Interbody 16x14x10 15°, STERILE
00810161110681	Stabilis NF Ti Cervical Interbody 16x14x10 10°, STERILE
00810161110674	Stabilis NF Ti Cervical Interbody 16x14x10 5°, STERILE
00810161110667	Stabilis NF Ti Cervical Interbody 16x14x9 15°, STERILE
00810161110650	Stabilis NF Ti Cervical Interbody 16x14x9 10°, STERILE
00810161110643	Stabilis NF Ti Cervical Interbody 16x14x9 5°, STERILE
00810161110636	Stabilis NF Ti Cervical Interbody 16x14x8 15°, STERILE
00810161110629	Stabilis NF Ti Cervical Interbody 16x14x8 10°, STERILE
00810161110612	Stabilis NF Ti Cervical Interbody 16x14x8 5°, STERILE
00810161110605	Stabilis NF Ti Cervical Interbody 16x14x7 15°, STERILE
00810161110599	Stabilis NF Ti Cervical Interbody 16x14x7 10°, STERILE
00810161110582	Stabilis NF Ti Cervical Interbody 16x14x7 5°, STERILE
00810161110575	Stabilis NF Ti Cervical Interbody 16x14x6 10°, STERILE
00810161110568	Stabilis NF Ti Cervical Interbody 16x14x6 5°, STERILE
00810161110551	Stabilis NF Ti Cervical Interbody 16x14x5 5°, STERILE
00810161110544	Stabilis NF Ti Cervical Interbody 14x12x12 15°, STERILE
00810161110537	Stabilis NF Ti Cervical Interbody 14x12x12 10°, STERILE
00810161110520	Stabilis NF Ti Cervical Interbody 14x12x12 5°, STERILE
00810161110513	Stabilis NF Ti Cervical Interbody 14x12x11 15°, STERILE
00810161110506	Stabilis NF Ti Cervical Interbody 14x12x11 10°, STERILE
00810161110490	Stabilis NF Ti Cervical Interbody 14x12x11 5°, STERILE
00810161110483	Stabilis NF Ti Cervical Interbody 14x12x10 15°, STERILE
00810161110476	Stabilis NF Ti Cervical Interbody 14x12x10 10°, STERILE
00810161110469	Stabilis NF Ti Cervical Interbody 14x12x10 5°, STERILE
00810161110452	Stabilis NF Ti Cervical Interbody 14x12x9 15°, STERILE
00810161110445	Stabilis NF Ti Cervical Interbody 14x12x9 10°, STERILE
00810161110438	Stabilis NF Ti Cervical Interbody 14x12x9 5°, STERILE
00810161110421	Stabilis NF Ti Cervical Interbody 14x12x8 15°, STERILE
00810161110414	Stabilis NF Ti Cervical Interbody 14x12x8 10°, STERILE
00810161110407	Stabilis NF Ti Cervical Interbody 14x12x8 5°, STERILE
00810161110391	Stabilis NF Ti Cervical Interbody 14x12x7 15°, STERILE
00810161110384	Stabilis NF Ti Cervical Interbody 14x12x7 10°, STERILE
00810161110377	Stabilis NF Ti Cervical Interbody 14x12x7 5°, STERILE
00810161110360	Stabilis NF Ti Cervical Interbody 14x12x6 10°, STERILE
00810161110353	Stabilis NF Ti Cervical Interbody 14x12x6 5°, STERILE
00810161110346	Stabilis NF Ti Cervical Interbody 14x12x5 5°, STERILE
00810161112234	Stabilis NF Ti Cervical Interbody 18x15x5 5°, STERILE
00810161111169	Stabilis NF Ti Cervical Interbody 20x16x12 15°, STERILE
00810161111152	Stabilis NF Ti Cervical Interbody 20x16x12 10°, STERILE
00810161111145	Stabilis NF Ti Cervical Interbody 20x16x12 5°, STERILE
00810161111138	Stabilis NF Ti Cervical Interbody 20x16x11 15°, STERILE
00810161111121	Stabilis NF Ti Cervical Interbody 20x16x11 10°, STERILE
00810161111114	Stabilis NF Ti Cervical Interbody 20x16x11 5°, STERILE
00810161111107	Stabilis NF Ti Cervical Interbody 20x16x10 15°, STERILE

Trademark Results [Stabilis]

Mark Image Registration \| Serial	Company Trademark Application Date
STABILIS 98578391 not registered Live/Pending	Yarnold, Adam 2024-05-31
STABILIS 98456259 not registered Live/Pending	Acuity Surgical Devices, LLC 2024-03-19
STABILIS 97859337 not registered Live/Pending	Wilbur-Ellis Company LLC 2023-03-27
STABILIS 97834824 not registered Live/Pending	LF BOLT CORP. 2023-03-12
STABILIS 88201393 5947550 Live/Registered	Stabilis Energy, LLC 2018-11-20
STABILIS 88124005 not registered Live/Pending	Hunter and Son Construction, Inc. 2018-09-19
STABILIS 87572531 not registered Dead/Abandoned	Stabilis Pro, LLC 2017-08-17
STABILIS 86656836 5519905 Live/Registered	THE BOARD OF REGENTS FOR OKLAHOMA STATEUNIVERSITY 2015-06-09
STABILIS 86032957 4650046 Live/Registered	Peerless Industriies, Inc. 2013-08-08
STABILIS 85515548 4411688 Live/Registered	Stabilis Capital Management, LP 2012-01-12
STABILIS 85363916 4124807 Live/Registered	The Prophet Corporation 2011-07-06
STABILIS 76174966 not registered Dead/Abandoned	STRYKER SPINE SA 2000-11-27