FDA.reportPublic FDA data

NA

Primary DI
10886705010943
Brand
NA
Company
DEPUY MITEK, LLC
Model
232013
Catalog number
232013
Device description
LIGAMENT SIZING SCALE 0 - 13mm (Plus or Minus 3 Percent)
Published
2015-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705010943PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670501094310886705010943

GMDN Terms#

Term, Definition table
TermDefinition
Ligament graft sizer, noninvasiveA non-sterile surgical instrument that contains a series of holes of varying diameters intended to be used in orthopaedic surgery [e.g., in anterior cruciate ligament (ACL) reconstruction surgery] to measure the diameter of a harvested graft to be implanted. It is used in vitro [e.g., on the preparation table of the operating room (OR)] on a harvested graft. The measurement is subsequently used to determine the diameter of the tunnel drilled into the operative site (e.g., distal femur) for acceptance of the new graft. The device may be made of polysulfone. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
190572854
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
10886705001804QUICKANCHOR ETHIBOND2120322120322015-09-01
10886705002535QUICKANCHOR ETHIBOND2128662128662015-09-01
10886705002542QUICKANCHOR ETHIBOND2128672128672015-09-01
10886705003747NA2145282145282015-09-01
10886705006892NA2198132198132017-03-17
10886705006908NA2198142198142017-03-17
10886705006922NA2198162198162017-03-17
10886705013098INTRAFIX2546032546032015-09-01
10886705013104NA2546042546042015-09-01
10886705013128INTRAFIX2546092546092015-09-01
10886705013531INTRAFIX2546712546712015-09-01
10886705020607FMS DUO2845802845802015-09-01
10886705020614FMS SOLO2845902845902015-09-01
10886705022397INTRAFIX2546532546532015-09-01
10886705023431HEALIX ADVANCE2223352223352015-09-01
10886705023455HEALIX ADVANCE2223332223332015-09-01
10886705023486HEALIX ADVANCE2223342223342015-09-01
10886705002399QUICKANCHOR ETHIBOND2128502128502015-09-01
10886705002405QUICKANCHOR ETHIBOND TAPERCUT2128512128512015-09-01
10886705002443MICROFIX QUICKANCHOR ETHIBOND2128552128552015-09-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850080243176OSTEOROD Delivery SystemBONE SOLUTIONS, INC.LXH2026-10-12
00889795150264APEX 3D Total Ankle Replacement SystemParagon 28, Inc.LXH2026-10-12
B0842003000000Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000010Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000020Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000030Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000100Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000110Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000120Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000130Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000200Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000210Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000220Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000230Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000300Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000310Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000320Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000330Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000400Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000410Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000420Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000430Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000500Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000510Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000520Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000530Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000600Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000610Keos Lumbar InstrumentKEOSLXH2023-02-10
B0842003000620Keos Lumbar InstrumentKEOSLXH2023-02-10