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
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
B41711140141Fuji Cervical Plate System111-40142017-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091278ELMED INCORPORATEDELMED INCORPORATEDLRP2026-06-09
04052536163434neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164585neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164592neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536164608neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536177516neon3Ulrich GmbH & Co. KGLRP2026-06-09
04052536221202uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221219uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536221233uCentumUlrich GmbH & Co. KGLRP2026-06-09
04052536162116neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162130neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162147neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162154neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536162215neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176724neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176748neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176755neon3Ulrich GmbH & Co. KGLRP2026-06-08
04052536176762neon3Ulrich GmbH & Co. KGLRP2026-06-08
10198956433755CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956461109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956476950CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956479999CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956485112CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956487475CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490109CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956490635CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956494817CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956501362CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956505841CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08
10198956506381CARDINAL HEALTHCardinal Health 200, LLCLRP2026-06-08