FDA.reportPublic FDA data

Tornier Perform Humeral System

Primary DI
00846832085873
Brand
Tornier Perform Humeral System
Company
TORNIER, INC.
Model
IFX08
Catalog number
IFX08
Device description
Fracture Stem Reamer
Published
2023-03-10
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
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832085873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832085873008468320858738468320858730846832085873

GMDN Terms#

Term, Definition table
TermDefinition
Medullary canal orthopaedic reamer, rigidAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840338607515Made-To-Order902706990270692026-04-28
00840338604033Tornier HRSARS10252ARS102522025-11-18
00840338604040Tornier HRSARS10253ARS102532025-11-18
00846832068678AEQUALIS™ FLEX REVIVE™ARS742301ARS7423012019-03-04
00846832068685AEQUALIS™ FLEX REVIVE™ARS742302ARS7423022019-03-04
00846832068692AEQUALIS™ FLEX REVIVE™ARS742303ARS7423032019-03-05
00846832068708AEQUALIS™ FLEX REVIVE™ARS742304ARS7423042019-03-04
00846832068715AEQUALIS™ FLEX REVIVE™ARS742305ARS7423052019-03-04
00846832068722AEQUALIS™ FLEX REVIVE™ARS742306ARS7423062019-03-04
00846832068739AEQUALIS™ FLEX REVIVE™ARS742401ARS7424012019-03-04
00846832068746AEQUALIS™ FLEX REVIVE™ARS742402ARS7424022019-03-04
00846832068777AEQUALIS™ FLEX REVIVE™ARS742405ARS7424052019-03-04
00846832068784AEQUALIS™ FLEX REVIVE™ARS742406ARS7424062019-03-04
00846832068814AEQUALIS™ FLEX REVIVE™ARS742501ARS7425012019-03-04
00846832068821AEQUALIS™ FLEX REVIVE™ARS742502ARS7425022019-03-04
00846832068838AEQUALIS™ FLEX REVIVE™ARS742503ARS7425032019-03-04
00846832068845AEQUALIS™ FLEX REVIVE™ARS742504ARS7425042019-03-04
00846832068852AEQUALIS™ FLEX REVIVE™ARS742505ARS7425052019-03-04
00846832068869AEQUALIS™ FLEX REVIVE™ARS742506ARS7425062019-03-04
00846832006588Futura™ FGTFGT-202015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWT2026-05-28
08033390108065SMR STEMLESSLIMACORPORATE SPAKWT2022-03-17
08033390106757BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106764BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106771BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106788BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106795BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106801BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106818BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106825BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106849BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106856BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106863BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106870BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106887BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106894BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106900BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106917BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106924BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106931BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390038935SMR Shoulder system LIMACORPORATE SPAKWT2018-09-21
08033390085984SMR Shoulder LIMACORPORATE SPAKWT2017-07-05
08033390087834SMR Shoulder LIMACORPORATE SPAKWT2017-07-05
08033390105866SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106412SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106429SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106436SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106443SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390108768SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390108775SMR ShoulderLIMACORPORATE SPAKWT2017-02-25