FDA.report

Affiniti™ Cortiloc™

Primary DI
00846832002146
Brand
Affiniti™ Cortiloc™
Company
TORNIER, INC.
Model
0020062
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Product Code Classifications

CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846832002146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846832002146008468320021468468320021460846832002146

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

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
true
Serial number
false
Manufacturing date on label
false
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

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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

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03661489523618JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723421JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723438JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723445JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723452JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723469JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723476JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723483JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723490JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723506JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723537JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16