FDA.reportPublic FDA data

Indy

Primary DI
90843210162594
Brand
Indy
Company
Altus Spine, LLC
Model
1020-3224-1
Device description
Implant Module Lid
Published
2024-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182406000Altus Spine Interbody Fusion SystemAltus Partners, LLC2019-02-22MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90843210162594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9084321016259490843210162594

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
610-355-4156QARA@Altus-Spine.com

Regulatory Flags#

DUNS number
078331322
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843210143644Monaco Pedicle Screw System880-10442026-08-24
00843210180731Brickyard Stand-Alone ALIF1030-04132024-08-29
00843210176611Indy Standalone1030-04132024-07-24
00843210133478Imola-Silverstone600-31092018-10-06
00843210134161Imola-Silverstone790-00022018-10-06
00843210176567Sochi300-09012025-03-13
00843210167381SochiA16-30-25352024-10-03
00843210167398SochiA16-30-31412024-10-03
00843210167404SochiA16-30-38482024-10-03
B41710010011Monza Cervical Plate System100-10012016-10-28
B41711040121Monza Cervical Plate System110-40122016-10-28
B41711040141Monza Cervical Plate System110-40142016-10-28
B41711040161Monza Cervical Plate System110-40162016-10-28
B41711040181Monza Cervical Plate System110-40182016-10-28
B41711043121Monza Cervical Plate System110-43122016-10-28
B41711043141Monza Cervical Plate System110-43142016-10-28
B41711043161Monza Cervical Plate System110-43162016-10-28
B41711043181Monza Cervical Plate System110-43182016-10-28
B41711140121Fuji Cervical Plate System111-40122017-08-22
B41711140131Fuji Cervical Plate System111-40132017-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G141588225750Carnegie Surgical LLCCarnegie Surgical LLCLRP2026-10-07
00810017915293Saber-XA, Trial CaddyELEVATION SPINE, INC.LRP2026-10-06
00810017915309SABER-XA, Screw CaddyELEVATION SPINE, INC.LRP2026-10-06
00810017915316SABER-XA, Cage & Plate Caddy, 34Wx26DELEVATION SPINE, INC.LRP2026-10-06
00810017915323SABER-XA, Cage & Plate Caddy, 37Wx28DELEVATION SPINE, INC.LRP2026-10-06
00810017915330SABER-XA, Cage & Plate Caddy, 40Wx30DELEVATION SPINE, INC.LRP2026-10-06
00810017915347SABER-XA, Spike CaddyELEVATION SPINE, INC.LRP2026-10-06
10198956339156CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956552340CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956584990CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956591660CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956592162CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956603684CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956604605CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956604698CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956605756CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956605831CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956606050CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956606302CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956608917CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-06
10198956498914CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956599437CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956599574CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956601581CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-30
10198956370487CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956539235CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956560406CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956578586CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956585065CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29
10198956587236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-09-29