FDA.reportPublic FDA data

TORNIER PERFORM™ Patient-Matched

Primary DI
00846832079438
Brand
TORNIER PERFORM™ Patient-Matched
Company
TORNIER, INC.
Model
MWJ203
Catalog number
MWJ203
Published
2022-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846832079438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832079438008468320794388468320794380846832079438

GMDN Terms#

Term, Definition table
TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

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
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWS2026-05-28
07613327603361REUNIONStryker GmbHKWS2024-10-01
07613327354331REUNIONStryker GmbHKWS2022-11-15
07613327354355REUNIONStryker GmbHKWS2022-11-15
07613327354805REUNIONStryker GmbHKWS2022-11-15
07613327354904REUNIONStryker GmbHKWS2022-11-15
07613327354935REUNIONStryker GmbHKWS2022-11-15
07613327354942REUNIONStryker GmbHKWS2022-11-15
07613327355024REUNIONStryker GmbHKWS2022-11-15
07613327355093REUNIONStryker GmbHKWS2022-11-15
07613327355109REUNIONStryker GmbHKWS2022-11-15
07613327355222REUNIONStryker GmbHKWS2022-11-15
07613327355246REUNIONStryker GmbHKWS2022-11-15
07613327355260REUNIONStryker GmbHKWS2022-11-15
07613327355291REUNIONStryker GmbHKWS2022-11-15
07613327355345REUNIONStryker GmbHKWS2022-11-15
07613327355369REUNIONStryker GmbHKWS2022-11-15
07613327355437REUNIONStryker GmbHKWS2022-11-15
07613327355444REUNIONStryker GmbHKWS2022-11-15
07613327355475REUNIONStryker GmbHKWS2022-11-15
07613327507096REUNIONStryker GmbHPHX2021-11-02
07613327354317REUNIONStryker GmbHPHX2021-04-27
07613327354348REUNIONStryker GmbHPHX2021-04-27
07613327354362REUNIONStryker GmbHPHX2021-04-27
07613327354393REUNIONStryker GmbHPHX2021-04-27
07613327354409REUNIONStryker GmbHKWS2021-04-27
07613327354409REUNIONStryker GmbHPHX2021-04-27
07613327354782REUNIONStryker GmbHPHX2021-04-27
07613327354812REUNIONStryker GmbHPHX2021-04-27
07613327354812REUNIONStryker GmbHKWS2021-04-27