FDA.reportPublic FDA data

Alphatec Spine

Primary DI
00190776149062
Brand
Alphatec Spine
Company
Avalign Technologies, Inc.
Model
89000-12
Device description
RIB STRIPPER ELEVATOR
Published
2022-04-10
Public version status
Update
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
00190776149062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776149062001907761490621907761490620190776149062

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevatorA hand-held 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
18772891096product.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
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424091MillenniumAvalign Technologies, Inc.GEG2026-08-27
00190776428297MillenniumAvalign Technologies, Inc.GEG2026-08-27
00190776427733MillenniumAvalign Technologies, Inc.GEG2026-08-26
00190776427245MillenniumAvalign Technologies, Inc.GEG2026-08-21
00190776422646MillenniumAvalign Technologies, Inc.GEG2026-08-03
00190776422851MillenniumAvalign Technologies, Inc.GEG2026-08-03
B382SD350110Surgical DirectSurgical Direct, Inc.GEG2026-08-03
B382SD38060Surgical DirectSurgical Direct, Inc.GEG2026-08-03
B382SD4833125SN0Surgical DirectSurgical Direct, Inc.GEG2026-08-03
00190776422448MillenniumAvalign Technologies, Inc.GEG2026-07-31
00810143904598SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904604SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904611SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904628SURGIPROSSurgipros, LLCGEG2026-07-30
00810143904642SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906264SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906325SURGIPROSSurgipros, LLCGEG2026-07-30
00810143906370SURGIPROSSurgipros, LLCGEG2026-07-30
00810143907254SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934068SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934075SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934082SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934099SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934105SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934112SURGIPROSSurgipros, LLCGEG2026-07-30
00810212934129SURGIPROSSurgipros, LLCGEG2026-07-30
B382SD914665600Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD914665630Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD914665700Surgical DirectSurgical Direct, Inc.GEG2026-07-27
B382SD914665730Surgical DirectSurgical Direct, Inc.GEG2026-07-27