FDA.report

Initia Total Hip System

Primary DI
04547898350511
Brand
Initia Total Hip System
Company
KYOCERA CORPORATION
Model
TJ40397
Catalog number
TJ40397
Device description
LINER INSERTER 44
Published
2018-03-29
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

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04547898350511PrimaryGS10

GMDN Terms

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
909-557-2360kmti.info@kyocera.com

Regulatory Flags

DUNS number
694697025
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04547898777561Initia Total Hip SystemTJ51146-1TJ51146-12023-05-24
04547898777578Initia Total Hip SystemTJ51146-2TJ51146-22023-05-24
04547898777585Initia Total Hip SystemTJ51146-3TJ51146-32023-05-24
04547898438974Initia Total Hip SystemTJ51147TJ511472022-12-06
04547898439025Initia Total Hip SystemTJ51146-1TJ51146-12022-12-06
04547898439032Initia Total Hip SystemTJ51146-2TJ51146-22022-12-06
04547898439049Initia Total Hip SystemTJ51146-3TJ51146-32022-12-06
04547898440434Initia Total Hip SystemTJ51461TJ514612022-12-06
04547898438080Initia Total Hip SystemTJ42890TJ428902022-11-09
04547898438233Initia Total Hip SystemTJ51247TJ512472022-11-09
04547898432491Initia Total Hip SystemTJ39639-1TJ39639-12021-11-30
04547898432507Initia Total Hip SystemTJ39641-1TJ39641-12021-11-30
04547898432514Initia Total Hip SystemTJ39643-1TJ39643-12021-11-30
04547898432521Initia Total Hip SystemTJ39645-1TJ39645-12021-11-30
04547898432538Initia Total Hip SystemTJ39647-1TJ39647-12021-11-30
04547898433979Initia Total Hip System21057-00-000021057-00-00002021-11-30
04547898304712Initia Total Hip SystemGMH02-500011GMH02-5000112017-02-21
04547898304729Initia Total Hip SystemGMH02-500012GMH02-5000122017-02-21
04547898304736Initia Total Hip SystemGMH02-500013GMH02-5000132017-02-21
04547898304743Initia Total Hip SystemGMH02-500014GMH02-5000142017-02-21

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