FDA.reportPublic FDA data

Integra® XT

Primary DI
10381780368656
Brand
Integra® XT
Company
Ascension Orthopedics, Inc.
Model
MJU907T
Device description
Tibial osteotome
Published
2017-05-04
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
HWMOSTEOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780368656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178036865610381780368656

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
942377524
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
10381780240310Cadence™102031932016-08-24
10381780245513BioMotion® Cannulated 1st MPJ Hemi SystemHM 3010HM 30102017-09-05
10381780245629Titan™IP0920055001IMP-0920-055-0012017-09-05
10381780245636Titan™IP0920064001IMP-0920-064-0012017-09-05
10381780245643Titan™IP0920079501IMP-0920-0795-012017-09-05
10381780245650Titan™IMP096006401IMP-0960-064-012017-09-05
10381780245667Titan™IMP096006601IMP-0960-066-012017-09-05
10381780245674Titan™IMP096007101IMP-0960-071-012017-09-05
10381780245681Ascension®IMP10000DIMP-100-00D2017-09-05
10381780245698Ascension®IMP10000PIMP-100-00P2017-09-05
10381780245704Integra®IMP20000DIMP-200-00D2017-09-05
10381780245711Integra®IMP20000PIMP-200-00P2017-09-05
10381780245728Integra®IMP30000IMP-300-002017-09-05
10381780245735Integra®IMP35000IMP-350-002017-09-05
10381780245759NuGrip® CMC Implant SystemIMP44200IMP-442-002017-09-05
10381780245766First Choice® DRUJ SystemIMP60000IMP-600-002017-09-05
10381780245780Movement®IMP-890-00MTIMP-890-00MT2017-09-05
10381780245797Movement®IMP-890-00PPIMP-890-00PP2017-09-05
10381780245803Integra®IMP90001IMP-900-012017-09-05
10381780245988Integra®MAL092008501MAL-0920-085-012017-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421861MillenniumAvalign Technologies, Inc.HWM2026-07-23
00190776400422MillenniumAvalign Technologies, Inc.HWM2026-07-17
00190776400439MillenniumAvalign Technologies, Inc.HWM2026-07-17
B756SBLDFLAT17010Shukla Blade S9BLADEShukla MedicalHWM2026-07-09
B756SBLDFLAT17020Shukla Blade S9BLADEShukla MedicalHWM2026-07-09
00810143904666SURGIPROSSurgipros, LLCHWM2026-06-01
00810143904673SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907261SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907278SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907308SURGIPROSSurgipros, LLCHWM2026-06-01
00810143907315SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930008SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930015SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930022SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930039SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930046SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930053SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930060SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930077SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930084SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930091SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930107SURGIPROSSurgipros, LLCHWM2026-06-01
00810212930114SURGIPROSSurgipros, LLCHWM2026-06-01
09348811099624INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811110442INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811111289INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
10381780503316Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503323Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503330Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503347Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01