FDA.report

Align

Primary DI
00810043483018
Brand
Align
Company
ACUITY SURGICAL DEVICES, LLC
Model
16-18451707
Device description
Align Ti Lateral Interbody 18x45x17 7°
Published
2024-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810043483018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810043483018008100434830188100434830180810043483018

GMDN Terms

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

TypeValueUnit
Angle7degree
Height17Millimeter
Length18Millimeter
Width45Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8442284890support@acuitysurgical.com

Regulatory Flags

DUNS number
025855111
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810192476657Tera20-1000007220-100000722026-02-10
00810192476664Tera20-1000007120-100000712026-02-10
00810192476671Tera20-1000007320-100000732026-02-10
00810161110766Stabilis30-18150605-SP2024-07-10
00810161110773Stabilis30-18150610-SP2024-07-10
00810161110780Stabilis30-18150705-SP2024-07-10
00810161110797Stabilis30-18150710-SP2024-07-10
00810161110803Stabilis30-18150715-SP 2024-07-10
00810161110810Stabilis30-18150805-SP2024-07-10
00810161110827Stabilis30-18150810-SP2024-07-10
00810161110834Stabilis30-18150815-SP2024-07-10
00810161110841Stabilis30-18150905-SP2024-07-10
00810161110858Stabilis30-18150910-SP2024-07-10
00810161110865Stabilis30-18150915-SP2024-07-10
00810161110872Stabilis30-18151005-SP2024-07-10
00810161110889Stabilis30-18151010-SP2024-07-10
00810161110896Stabilis30-18151015-SP2024-07-10
00810161110902Stabilis30-18151105-SP2024-07-10
00810161110919Stabilis30-18151110-SP2024-07-10
00810161110926Stabilis30-18151115-SP2024-07-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810141040007Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCOVD2026-03-05
10889981304713MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981304720MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981326241REEF LSeaspine Orthopedics CorporationOVD2026-03-03
00840067210710TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210727TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210734TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210741TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210758TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210765TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210772TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210789TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210796TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210802TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210819TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210826TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210833TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210840TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210857TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210864TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210871TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210888TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210895TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210901TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210918TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210925TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210932TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210949TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210956TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210963TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20