FDA.reportPublic FDA data

Aequalis Pyrocarbon Humeral Head

Primary DI
03700386999055
Brand
Aequalis Pyrocarbon Humeral Head
Company
TORNIER
Model
MWF763
Catalog number
MWF763
Device description
SPACER FOR PYROCARBON HEAD TRIAL
Published
2023-01-06
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
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
03700386999055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700386999055037003869990553700386999055

GMDN Terms#

Term, Definition table
TermDefinition
Humeral head spacer prosthesis trialA copy of a final humeral head spacer designed to be used before primary or revision implant surgery to validate the appropriate size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is disk-like in shape and made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.

Contacts#

Phone, Email table
PhoneEmail
+330476613500order@tornier.com

Regulatory Flags#

DUNS number
260324876
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
03700386957871Flex Shoulder SystemTORNIERQKW2023-01-06
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