FDA.reportPublic FDA data

Spinal Elements

Primary DI
00190776406141
Brand
Spinal Elements
Company
Avalign Technologies, Inc.
Model
69108-520
Device description
Posterior Vertebral Body Punch, 5mm x 20mm
Published
2025-03-21
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
KXHCradle, Patient, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXHCradle, Patient, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776406141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776406141001907764061411907764061410190776406141

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
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
00850043319153Hyperfine Foam Back PadHyperfine Operations, Inc.KXH2026-05-26
07640178060753MultipadPearl Technology AGKXH2025-12-17
07640178060760PearlFitPearl Technology AGKXH2025-12-17
07640178060852PearlFitPearl Technology AGKXH2025-12-17
07640178060906PearlFitPearl Technology AGKXH2025-12-17
07640178060982ProFoamPearl Technology AGKXH2025-12-17
07640178060999ProFoamPearl Technology AGKXH2025-12-17
07640178061002ProFoamPearl Technology AGKXH2025-12-17
07640178061019ProFoamPearl Technology AGKXH2025-12-17
07640178061750ProFoamPearl Technology AGKXH2025-12-17
07640178061767ProFoamPearl Technology AGKXH2025-12-17
07640178061774ProFoamPearl Technology AGKXH2025-12-17
07640178061781ProFoamPearl Technology AGKXH2025-12-17
07640178061804ProBeltPearl Technology AGKXH2025-12-17
07640178061859ProFoamPearl Technology AGKXH2025-12-17
07640178061866ProFoamPearl Technology AGKXH2025-12-17
07640178061873ProFoamPearl Technology AGKXH2025-12-17
07640178061880ProFoamPearl Technology AGKXH2025-12-17
07640178061897ProBeltPearl Technology AGKXH2025-12-17
07640178061903ProFoamPearl Technology AGKXH2025-12-17
07640178061910ProFoamPearl Technology AGKXH2025-12-17
07640178062085ProFoamPearl Technology AGKXH2025-12-17
07640178062092ProFoamPearl Technology AGKXH2025-12-17
07640178062108ProFoamPearl Technology AGKXH2025-12-17
07640178062115ProFoamPearl Technology AGKXH2025-12-17
07640178062122ProFoamPearl Technology AGKXH2025-12-17
07640178062139ProFoamPearl Technology AGKXH2025-12-17
07640178062146ProFoamPearl Technology AGKXH2025-12-17
07640178062153ProFoamPearl Technology AGKXH2025-12-17
07640178062078pearltecPearl Technology AGKXH2025-07-28