FDA.reportPublic FDA data

A Link Z

Primary DI
00850812008950
Brand
A Link Z
Company
ACUITY SURGICAL DEVICES, LLC
Model
14-38301716
Device description
A Link Z Ti Unitary Interbody 38x30x17 16°
Published
2024-01-31
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
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201671000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201671000A-Link ZAcuity Surgical Devices, LLC2021-05-04OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850812008950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850812008950008508120089508508120089500850812008950

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 in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical 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 included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle16degree
Height17Millimeter
Length38Millimeter
Width30Millimeter

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
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
07613153046196AVS PLStryker CorporationOVD2015-09-14
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07613153046288AVS PLStryker CorporationOVD2015-09-14
07613153046295AVS PLStryker CorporationOVD2015-09-14
07613153046318AVS PLStryker CorporationOVD2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14
07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14
07613153046400AVS TLStryker CorporationOVD2015-09-14
07613153046417AVS TLStryker CorporationOVD2015-09-14
07613153046431AVS TLStryker CorporationOVD2015-09-14
07613153046448AVS TLStryker CorporationOVD2015-09-14
07613153046455AVS TLStryker CorporationOVD2015-09-14
07613153046516AVS TLStryker CorporationOVD2015-09-14
07613153046523AVS TLStryker CorporationOVD2015-09-14
07613153046554AVS TLStryker CorporationOVD2015-09-14
07613153046561AVS TLStryker CorporationOVD2015-09-14
07613153046578AVS TLStryker CorporationOVD2015-09-14
07613153046585AVS TLStryker CorporationOVD2015-09-14
07613153046592AVS TLStryker CorporationOVD2015-09-14
07613153046608AVS TLStryker CorporationOVD2015-09-14
07613153046615AVS TLStryker CorporationOVD2015-09-14
07613153046622AVS TLStryker CorporationOVD2015-09-14
07613153046639AVS TLStryker CorporationOVD2015-09-14
07613153046646AVS TLStryker CorporationOVD2015-09-14
07613153046653AVS TLStryker CorporationOVD2015-09-14
07613153046660AVS TLStryker CorporationOVD2015-09-14
07613153046677AVS TLStryker CorporationOVD2015-09-14
07613153046691AVS TLStryker CorporationOVD2015-09-14