FDA.reportPublic FDA data

TORNIER PERFORM™ HUMERAL SYSTEM

Primary DI
00846832085095
Brand
TORNIER PERFORM™ HUMERAL SYSTEM
Company
TORNIER, INC.
Model
DWT110
Catalog number
DWT110
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

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
00846832085095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832085095008468320850958468320850950846832085095

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder humeral body prosthesisA sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a modular shoulder replacement system.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862648532EquinoxeExactech, Inc.KWT2026-03-19
10885862650429EquinoxeExactech, Inc.KWT2026-03-19
08033390272797SMR SystemLIMACORPORATE SPAKWT2026-02-25
08033390272803SMR SystemLIMACORPORATE SPAKWT2026-02-25
08033390272810SMR SystemLIMACORPORATE SPAKWT2026-02-25
10885862657046CSBExactech, Inc.KWT2026-01-28
10885862657053CSBExactech, Inc.KWT2026-01-28
B1132L1S0400020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0600020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0600030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0800020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S0800030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1000020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1000030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1200020Shoulder Innovations InSet FxR 135Shoulder Innovations, Inc.KWT2025-12-12
B1132L1S1200030Shoulder Innovations InSet FxR 185Shoulder Innovations, Inc.KWT2025-12-12
B1132L2HB000020Shoulder Innovations InSet 135 Instrument Case/TrayShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB000030Shoulder Innovations InSet 185 Instrument Case/TrayShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235040Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235060Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235080Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235100Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB235120Shoulder Innovations InSet FxR 135 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285060Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285080Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285100Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HB285120Shoulder Innovations InSet FxR 185 Humeral Stem TrialShoulder Innovations, Inc.KWT2025-12-12
B1132L2HI135010Shoulder Innovations InSet 135 Impaction Stand TowerShoulder Innovations, Inc.KWT2025-12-12
B1132L2HI135020Shoulder Innovations InSet 135/185 Impaction Stand BaseShoulder Innovations, Inc.KWT2025-12-12
B1132L2HI135030Shoulder Innovations InSet 135/185 Adjustable FootShoulder Innovations, Inc.KWT2025-12-12