FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776344382
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
85-289402
Device description
Cobb Spinal Elevator,
Published
2023-09-28
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
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776344382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776344382001907763443821907763443820190776344382

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800102Adler Instrument CompanyAdler, Inc.GEG2026-05-26
00190776417987MillenniumAvalign Technologies, Inc.GEG2026-03-23
00190776417536MillenniumAvalign Technologies, Inc.GEG2026-02-27
B382SD9141051070Surgical DirectSurgical Direct, Inc.GEG2026-02-17
00190776416577MillenniumAvalign Technologies, Inc.GEG2026-02-16
B382SD62432250Surgical DirectSurgical Direct, Inc.GEG2026-02-16
B382SD9141051050Surgical DirectSurgical Direct, Inc.GEG2026-02-16
B382SD23020Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD23030Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD671050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD6716050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9141051060Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9141051080Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9206611040Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD921316170Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD921381050Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD92263910000Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD9226411030Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD922658020Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD923862510Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD940111100Surgical DirectSurgical Direct, Inc.GEG2026-02-09
B382SD1467010200Surgical DirectSurgical Direct, Inc.GEG2026-02-06
B382SD481003700Surgical DirectSurgical Direct, Inc.GEG2026-02-06
B382SD48820100Surgical DirectSurgical Direct, Inc.GEG2026-02-06
G3831056WM853543SURJEXSURJEXGEG2026-01-31
00190776415501MillenniumAvalign Technologies, Inc.GEG2026-01-27
00810123209743Adler Instrument CompanyAdler, Inc.GEG2026-01-02
00841336106802Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
00841336106819Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCGEG2025-12-22
B382SD91010Surgical DirectSurgical Direct, Inc.GEG2025-12-02