FDA.reportPublic FDA data

Stabilis

Primary DI
00810161114115
Brand
Stabilis
Company
ACUITY SURGICAL DEVICES, LLC
Model
35-20160905
Device description
Stabilis Cervical 20mm x 16mm x 9mm x 5 deg Trial
Published
2024-07-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230639000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230639000Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC2023-12-01ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810161114115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810161114115008101611141158101611141150810161114115

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle5degree
Height9Millimeter
Length20Millimeter
Width16Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8442284890support@acuitysurgical.com

Regulatory Flags#

DUNS number
025855111
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810192476657Tera20-1000007220-100000722026-02-10
00810192476664Tera20-1000007120-100000712026-02-10
00810192476671Tera20-1000007320-100000732026-02-10
00810043485043Align11-102550-SP2023-01-11
00810043485050Align11-140003-SP2023-01-11
00810043485210Align11-102050-SP2023-01-11
00810043485227Align11-102055-SP2023-01-11
00810043485234Align11-102555-SP2023-01-11
00810043485241Align11-103050-SP2023-01-11
00810043485258Align11-103055-SP2023-01-11
00810161113101Stabilis35-141205002024-07-11
00810161113118Stabilis35-141205052024-07-11
00810161113125Stabilis35-141206002024-07-11
00810161113132Stabilis35-141206052024-07-11
00810161113149Stabilis35-141206102024-07-11
00810161113156Stabilis35-141207002024-07-11
00810161113163Stabilis35-141207052024-07-11
00810161113170Stabilis35-141207102024-07-11
00810161113187Stabilis35-141207152024-07-11
00810161113194Stabilis35-141208002024-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221370419SCARLET® AC-TiSpineArt SAODP2025-11-10
07640221370464SCARLET® AC-TiSpineArt SAODP2025-11-10
07640221370471SCARLET® AC-TiSpineArt SAODP2025-11-10
07640164849645icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2025-06-02
07640164849652icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2025-06-02
07640164849669icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2025-06-02
07640164849676icotec Cervical Cage, Cervical Cage Anatomic, Container Rackicotec AGODP2025-06-02
07640332477991SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478004SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332478011SCARLET® AC-TiSpineArt SAODP2024-08-05
07640332477984SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478684SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478691SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478707SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478714SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478721SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478738SCARLET® AC-TiSpineArt SAODP2024-08-02
07640332478745SCARLET® AC-TiSpineArt SAODP2024-08-02
07640172551400icotec Cervical Cage, Inserter Sleeve, longicotec AGODP2021-09-01
07640172551417icotec Cervical Cage, Inserter Rod, longicotec AGODP2021-09-01
07640185341760SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341784SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341807SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-08
07640185341746SCARLET® AC-T Secured Anterior Cervical CageSpineArt SAODP2019-03-07
07640140433363icotec Lumbar Cage, Slotted Hammericotec AGODP2018-07-16
07640140433783icotec Cervical Cage, Cervical Cage Anatomic, Container, completeicotec AGODP2018-07-16
07640140433790icotec Cervical Cage, Cervical Cage Anatomic, Container Baseicotec AGODP2018-07-16
07640140433806icotec Cervical Cage, Cervical Cage Anatomic, Container Lidicotec AGODP2018-07-16
07640140433813icotec Cervical Cage, Anatomic Probe, 5 mm x 13 mmicotec AGODP2018-07-16
07640140433820icotec Cervical Cage, Anatomic Probe, 6 mm x 13 mmicotec AGODP2018-07-16