Shoulder Innovations TSA

Primary DI
B1132N2AI200050
Brand
Shoulder Innovations TSA
Company
Shoulder Innovations, Inc.
Model
20 mm x 5°
Catalog number
2N2AI20005
Device description
Shoulder Innovations InSet Plus Glenoid Implant, Circular In Line Peg, 20mm x 5°, UHMWPE
Published
2021-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1132N2AI200050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder glenoid fossa prosthesis, prefabricatedAn implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
616.294.1026info@shoulderinnovations.com

Regulatory Flags#

DUNS number
080404519
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1130S1GK000030Shoulder Innovations InSet 70 Humeral StemK-Wire, 2.4mm x 90mm0S1GK000032025-09-18
B1130S1GK000020Shoulder Innovations Humeral Short Stem SystemK-Wire Guide0S1GK000022023-11-28
B1132N1HG000000Shoulder Innovations Humeral Short Stem SystemK-Wire Guide2N1HG000002023-10-03
B1132N1IA000010Shoulder Innovations Humeral Short Stem SystemK-Wire 1.6mm2N1IA000012023-10-03
B1130S1GK00020SHOULDER INNOVATIONS TSA SYSTEMK WIRE0S1GK00022018-06-30
B1132G1HB300010Shoulder Innovations Humeral Stemless SystemStemless Broach - Minus2G1HB300012026-05-04
B1132G1HB300020Shoulder Innovations Humeral Stemless SystemStemless Broach - Standard2G1HB300022026-05-04
B1132R1NET20360Shoulder Innovations Inset Reverse Total ShoulderN22 Eccentric EZ Glenosphere - 36mm Diameter x 2mm2R1NET20362026-01-19
B1132R1NET30390Shoulder Innovations Inset Reverse Total ShoulderN22 Eccentric EZ Glenosphere - 39mm Diameter x 3mm2R1NET30392026-01-19
B1132R1NET40420Shoulder Innovations Inset Reverse Total ShoulderN22 Eccentric EZ Glenosphere - 42mm Diameter x 4mm2R1NET40422026-01-19
B1132R1NLT03330Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 33mm Diameter x 02R1NLT03332026-01-19
B1132R1NLT03360Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 36mm Diameter x 02R1NLT03362026-01-19
B1132R1NLT03390Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 39mm Diameter x 02R1NLT03392026-01-19
B1132R1NLT03420Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 42mm Diameter x 02R1NLT03422026-01-19
B1132R1NLT06330Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 33mm Diameter x 02R1NLT06332026-01-19
B1132R1NLT06360Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 36mm Diameter x 02R1NLT06362026-01-19
B1132R1NLT06390Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 39mm Diameter x 02R1NLT06392026-01-19
B1132R1NLT06420Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 42mm Diameter x 02R1NLT06422026-01-19
B1132R1NST00330Shoulder Innovations Inset Reverse Total ShoulderN22 Standard EZ Glenosphere - 33mm Diameter x 0mm 2R1NST00332026-01-19
B1132R1NST00360Shoulder Innovations Inset Reverse Total ShoulderN22 Standard EZ Glenosphere - 36mm Diameter x 0mm 2R1NST00362026-01-19

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