FDA.reportPublic FDA data

Align

Primary DI
00810043485180
Brand
Align
Company
ACUITY SURGICAL DEVICES, LLC
Model
35-50000001-1
Device description
Align Cervical Instrument Tray, Lid
Published
2024-01-19
Public version status
New
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
K221535000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221535000Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC2022-07-22MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810043485180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810043485180008100434851808100434851800810043485180

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

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
00197157074050ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074067ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074074ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074081ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074098ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074104ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074111ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074128ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074135ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074142ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074159ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074166ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074173ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074180ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074197ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074203ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074210ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074227ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074234ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074241ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074258ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074265ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074272ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074289ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074296ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074302ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074319ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074326ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074333ZAVATION SCREWZavation LLCOVD2026-05-29
00197157074340ZAVATION SCREWZavation LLCOVD2026-05-29