FDA.reportPublic FDA data

TORNIER PERFORM™ HUMERAL SYSTEM

Primary DI
00846832082360
Brand
TORNIER PERFORM™ HUMERAL SYSTEM
Company
TORNIER, INC.
Model
MWX100
Catalog number
MWX100
Published
2022-04-07
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
00846832082360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832082360008468320823608468320823600846832082360

GMDN Terms#

Term, Definition table
TermDefinition
Osteotomy guide, reusableA surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). 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(888)494-7950customerservice@tornier.com

Regulatory Flags#

DUNS number
968990812
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
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
08033390109550SMR ShoulderLIMACORPORATE SPAKWT2017-02-25