FDA.reportPublic FDA data

Millennium

Primary DI
00190776413477
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-398003
Device description
"Small Ball Spike 6.5mm Overall Length 8.5"" "
Published
2025-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776413477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776413477001907764134771907764134770190776413477

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic ball spikeA hand-held manual surgical instrument used in the surgical wound to reposition a bone fragment during a surgical intervention. It is typically a robust instrument designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a singularly pointed ball head at the distal end. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon to reposition and hold bone fragments. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776395377Millennium85-780896782026-07-13
00190776395384Millennium85-580023972026-07-13
00190776395391Millennium85-570004952026-07-13
00190776395407Millennium85-570004902026-07-13
00190776395414Millennium85-570004852026-07-13
00190776395421Millennium85-570004802026-07-13
00190776395438Millennium85-590083122026-07-13
00190776391683CONDUIT ZERO-P VA4514021002026-07-10
00190776391690CONDUIT ZERO-P VA4514021102026-07-10
00190776391706CONDUIT ZERO-P VA4514021202026-07-10
00190776391713CONDUIT ZERO-P VA4514030502026-07-10
00190776391720CONDUIT ZERO-P VA4514030602026-07-11
00190776391737CONDUIT ZERO-P VA4514030702026-07-11
00190776391744CONDUIT ZERO-P VA4514030802026-07-11
00190776391751CONDUIT ZERO-P VA4514030902026-07-11
00190776391768CONDUIT ZERO-P VA4514031002026-07-11
00190776391775CONDUIT ZERO-P VA4514031102026-07-11
00190776391782CONDUIT ZERO-P VA4514031202026-07-11
00190776391799CONDUIT ZERO-P VA4515010502026-07-11
00190776391805CONDUIT ZERO-P VA4515010602026-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606188128Ventana ASPINAL ELEMENTS, INC.LXH2026-07-13
B382SD9141791400Surgical DirectSurgical Direct, Inc.LXH2026-07-13
B382SD9142211000Surgical DirectSurgical Direct, Inc.LXH2026-07-13
00199150075034Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-10
07640177820907Neo Medical Pedicle screw kitNeo Medical SALXH2026-07-10
00840286860093Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860109Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00840286860116Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.LXH2026-07-09
00190446924838Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948469Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00190446948476Arsenal FootTrilliant Surgical, LLCLXH2026-06-24
00840067212189TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212196TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212202TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212219TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212226TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212233TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212240TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212257TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212264TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212271TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212288TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212295TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212301TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00840067212318TrellOss®-A SANEXXT SPINE, LLCLXH2026-06-24
00889929072752NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072769NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072776NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
00889929072783NEXXT MATRIXX® Stand Alone ALIF SystemNEXXT SPINE, LLCLXH2026-06-24
04046826486631Stern-a-Fix Sternal Closure SystemMedicon eG. Chirurgiemechaniker-GenossenschaftLXH2026-06-24