FDA.report

TORNIER PERFORM™ HUMERAL SYSTEM

Primary DI
00846832085392
Brand
TORNIER PERFORM™ HUMERAL SYSTEM
Company
TORNIER, INC.
Model
DWX1PS
Catalog number
DWX1PS
Published
2022-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Product Code Classifications

CodeDeviceSpecialtyClass
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846832085392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832085392008468320853928468320853920846832085392

GMDN Terms

TermDefinition
Coated shoulder humeral stem prosthesisA sterile implantable device designed to provide fixation within the proximal humerus and a site of attachment for a humeral head or humeral body prosthesis as part of a shoulder joint replacement. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)494-7950customerservice@tornier.com

Regulatory Flags

DUNS number
968990812
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00846832077632PERFORM™ HUMERAL SYSTEMDWR13602020-11-10
00846832077649PERFORM™ HUMERAL SYSTEMDWR13632020-11-10
00846832077656PERFORM™ HUMERAL SYSTEMDWR13662020-11-10
00846832077663PERFORM™ HUMERAL SYSTEMDWR13902020-11-10
00846832077670PERFORM™ HUMERAL SYSTEMDWR13932020-11-10
00846832077687PERFORM™ HUMERAL SYSTEMDWR13962020-11-10
00846832077694PERFORM™ HUMERAL SYSTEMDWR23602020-11-10
00846832077700PERFORM™ HUMERAL SYSTEMDWR23632020-11-10
00846832077717PERFORM™ HUMERAL SYSTEMDWR23662020-11-10
00846832077724PERFORM™ HUMERAL SYSTEMDWR23902020-11-10
00846832077731PERFORM™ HUMERAL SYSTEMDWR23932020-11-10
00846832077748PERFORM™ HUMERAL SYSTEMDWR23962020-11-10
00846832077755PERFORM™ HUMERAL SYSTEMDWR24202020-11-10
00846832077762PERFORM™ HUMERAL SYSTEMDWR24232020-11-10
00846832077779PERFORM™ HUMERAL SYSTEMDWR24262020-11-10
00846832077786PERFORM™ HUMERAL SYSTEMDWR33302020-11-10
00846832077793PERFORM™ HUMERAL SYSTEMDWR33332020-11-10
00846832077809PERFORM™ HUMERAL SYSTEMDWR33362020-11-10
00846832077816PERFORM™ HUMERAL SYSTEMDWR33602020-11-10
00846832077823PERFORM™ HUMERAL SYSTEMDWR33632020-11-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00887868580710Identity® Shoulder SystemZimmer, Inc.PAO2024-09-09
00887868580758Identity® Shoulder SystemZimmer, Inc.PAO2024-09-09
04026575439751LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-07-12
04026575534746LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-07-11
04026575439546LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439553LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439560LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439577LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533510LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533527LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533534LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533541LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533558LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533565LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533572LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533589LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533596LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533602LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533619LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533626LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533633LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533640LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533411LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533428LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533442LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533657LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533718LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533725LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533732LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533749LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22