FDA.reportPublic FDA data

Stryker Spine

Primary DI
00190776148720
Brand
Stryker Spine
Company
Avalign Technologies, Inc.
Model
48920014
Device description
8mm x 6mm Vertebral Body Osteotome
Published
2023-11-14
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
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776148720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776148720001907761487201907761487200190776148720

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
+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
10381780408567Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408574Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408581Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408680Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408703Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408710Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408727Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408734Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408741Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408758Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408765Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780408772Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-05-03
10381780188087Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188094Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188100Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188117Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188124Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188131Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188148Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188155Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188162Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188179Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188186Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188193Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188209Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188216Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188223Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188230Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188346Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02
10381780188353Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGFI2018-04-02