FDA.reportPublic FDA data

Flex Shoulder System

Primary DI
03700386957871
Brand
Flex Shoulder System
Company
TORNIER
Model
MWF720
Catalog number
MWF720
Device description
IMPACTOR TIP SUPPORT
Published
2023-01-06
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
QKWShoulder joint humeral (hemi-shoulder) ceramic head/metallic stem cemented or uncemented prosthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKWShoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented ProsthesisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220012000Tornier Pyrocarbon Humeral HeadTornier S.A.S.2022-12-16QKW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700386957871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700386957871037003869578713700386957871

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.

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
+330476613500order@tornier.com

Regulatory Flags#

DUNS number
260324876
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
03700386968303Aequalis FractureMWA302MWA3022022-08-08
03700386915260AEQUALISDWB1512015-10-16
03700386916144AEQUALIS REVERSEDDWB9352015-10-16
03700386916151AEQUALIS REVERSEDDWB9362015-10-16
03700386916618AEQUALIS REVERSEDDWD0022015-10-16
03700386916731AEQUALIS REVERSEDDWD0692015-10-16
03700386931529AEQUALIS REVERSED ADAPTERDWD8632015-10-16
03700386931536AEQUALIS REVERSED ADAPTERDWD8642015-10-16
03700386931543AEQUALIS REVERSED ADAPTERDWD8652015-10-16
03700386925726BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0212017-04-03
03700386955648BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0032016-09-11
03700386955655BLUEPRINT™ PATIENT SPECIFIC INSTRUMENTATIONMWJ0042017-04-03
03700386915062AEQUALIS GLENOIDDWB0012016-01-28
03700386915079AEQUALIS GLENOIDDWB0022015-10-16
03700386915086AEQUALIS GLENOIDDWB0032015-10-16
03700386915093AEQUALIS GLENOIDDWB0052015-10-16
03700386915109AEQUALIS GLENOIDDWB0062015-10-16
03700386915413AEQUALIS GLENOIDDWB2102015-10-16
03700386915420AEQUALIS GLENOIDDWB2112015-10-16
03700386915437AEQUALIS GLENOIDDWB2122015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700434019025Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434019469Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434019544Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434019643Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434019940Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434019988Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434020205Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434020267Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434020366Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434020441Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434020823Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434021301Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434021318Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434021356Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434021387Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434021608Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434021752Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434021776Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434022162Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700434022421Tornier Flex Shoulder SystemTORNIERQKW2023-01-10
03700386999055Aequalis Pyrocarbon Humeral HeadTORNIERQKW2023-01-06
03700386957888Flex Shoulder SystemTORNIERQKW2023-01-06
03700386957895Flex Shoulder SystemTORNIERQKW2023-01-06
03700386957901Flex Shoulder SystemTORNIERQKW2023-01-06
03700386957918Flex Shoulder SystemTORNIERQKW2023-01-06
03700386957925Flex Shoulder SystemTORNIERQKW2023-01-06
03700386957932Flex Shoulder SystemTORNIERQKW2023-01-06
03700386957949Flex Shoulder SystemTORNIERQKW2023-01-06
03700386957970Flex Shoulder SystemTORNIERQKW2023-01-06
03700386987991Flex Shoulder SystemTORNIERQKW2023-01-06