FDA.report

U2™ Knee

Primary DI
04719872158103
Brand
U2™ Knee
Company
UNITED ORTHOPEDIC CORP.
Model
9303-7302-RE
Catalog number
9303-7302-RE
Device description
Femoral sizer, posterior ref.
Published
2017-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KTZCaliper

Product Code Classifications

CodeDeviceSpecialtyClass
KTZCaliperOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04719872158103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04719872158103047198721581034719872158103

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+886229294567service@uoc.com.tw

Regulatory Flags

DUNS number
656700556
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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