FDA.reportPublic FDA data

Millennium

Primary DI
00190776370466
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
1-4560
Device description
Sanders Femoral Neck Cutting Block
Published
2023-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776370466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776370466001907763704661907763704660190776370466

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800200200079Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
08800200200086Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
00889024706965PSN 10MM M/L SHIFT BLOCKZimmer, Inc.FZX2026-03-19
03662663143462MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143479MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143486MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143493MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143509MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143516MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143523MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143530MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
00763000885212n/aMEDTRONIC SOFAMOR DANEK, INC.FZX2026-03-16
00840277133410Innomed, Inc.INNOMED, INC.FZX2026-03-11
10705034578866N/AMedos International SàrlFZX2026-03-05
10705034578873N/AMedos International SàrlFZX2026-03-05
10705034578880N/AMedos International SàrlFZX2026-03-05
10705034578897N/AMedos International SàrlFZX2026-03-05
00841435120402TecometTECOMET INC.FZX2026-02-27
09421038411889Adj Dist Fem Alignment Guide – CartilageENZTEC LIMITEDFZX2026-02-27
09421038411896Adj Dist Fem Alignment Guide – PaddleENZTEC LIMITEDFZX2026-02-27
09421038411902Sagittal Alignment Connector - PivotENZTEC LIMITEDFZX2026-02-27
09421038411919Sagittal Alignment Connector - Pivot with FanENZTEC LIMITEDFZX2026-02-27
09421038411926Dist Fem Cut Block Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411933Dist Fem Cut Block Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411940Dist Fem Cut Block Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411964Dist Fem Cut Block Slot Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411971Dist Fem Cut Block Slot Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411988Dist Fem Cut Block – 1.27mmENZTEC LIMITEDFZX2026-02-27
09421038411995IM Rod – 8mm x 135mmENZTEC LIMITEDFZX2026-02-27