FDA.report

SHOULDER INNOVATIONS TSA SYSTEM

Primary DI
B1130S1CI220080
Brand
SHOULDER INNOVATIONS TSA SYSTEM
Company
SHOULDER INNOVATIONS, LLC
Model
GLENOID TRIAL 22MM X 8MM
Catalog number
0S1CI22008
Published
2018-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Product Code Classifications

CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B1130S1CI220080PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
616 294-1026matt@shoulderinnovations.com

Regulatory Flags

DUNS number
080404519
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B1132N1AB00003SHOULDER INNOVATIONS TSA SYSTEMInSet Plus Case Base2N1AB000032020-06-08
B1130S1GG00020Shoulder Innovations TSA SystemPeripheral Drill Guide 20mm0S1GG000202021-05-04
B1130S1GR20065SHOULDER INNOVATIONS TSA SYSTEMREAMER/DRILL 20MM0S1GR200652021-05-04
B1130S1GR22065SHOULDER INNOVATIONS TSA SYSTEMREAMER/DRILL 22MM0S1GR220652021-05-04
B1130S1SI20006SHOULDER INNOVATIONS TSA SYSTEMSS GLENOID TRIAL 20MM X 6MM0S1SI220062021-05-04
B1130S1SI20008SHOULDER INNOVATIONS TSA SYSTEMSS GLENOID TRIAL 20MM X 8MM0S1SI200082021-05-04
B1132N1AC20005Shoulder Innovations TSA20 mm x 5°2N1AC200052021-05-04
B1132N1AC20010Shoulder Innovations TSA20 mm x 10°2N1AC200102021-05-04
B1132N1AC22005Shoulder Innovations TSA22 mm x 5°2N1AC220052021-05-04
B1132N1AC22010Shoulder Innovations TSA22 mm x 10°2N1AC220102021-05-04
B1132N1AC24005Shoulder Innovations TSA24 mm x 5°2N1AC240052021-05-04
B1132N1AC24010Shoulder Innovations TSA24 mm x 10°2N1AC240102021-05-04
B1132N1AC27005Shoulder Innovations TSA27 mm x 5°2N1AC270052021-05-04
B1132N1AC27010Shoulder Innovations TSA27 mm x 10°2N1AC270102021-05-04
B1132N1AC30005Shoulder Innovations TSA30 mm x 5°2N1AC300052021-05-04
B1132N1AC30010Shoulder Innovations TSA30 mm x 10°2N1AC300102021-05-04
B1132N1AL00002SHOULDER INNOVATIONS TSA SYSTEMCase Lid2N1AL000022021-05-04
B1132N1BS000280Shoulder Innovations Humeral Short Stem System28mm Broach2N1BS000282021-03-05
B1132N1GD000010Shoulder Innovations TSA SystemAnatomic Sizer Disk Handle - 0 degree2N1GD000012021-02-17
B1132N1GD000200Shoulder Innovations TSA SystemAnatomic Sizer Disk - 20mm2N1GD000202021-02-17

Other Devices Sharing Product Codes

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10885862648549EquinoxeExactech, Inc.KWS2026-03-19
10885862648556EquinoxeExactech, Inc.KWS2026-03-19
10885862648563EquinoxeExactech, Inc.KWS2026-03-19
10885862656582EquinoxeExactech, Inc.KWS2026-02-09
00840338607669Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338607713Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338607720Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612342Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612366Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612373Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00840338612380Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.KWS2026-01-21
00889024692794Augmented BP Reamer Guide ExtractorBiomet Orthopedics, LLCKWS2025-12-18
00889024703742Versa-Dial® Shoulder SystemBiomet Orthopedics, LLCKWS2025-12-09
00885556919354AETOS Shoulder SystemSmith & Nephew, Inc.KWS2025-11-17
00889024691476Identity HumeralZimmer, Inc.KWS2025-09-22
00889024691445Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691490Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691599Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691605Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691612Identity HumeralZimmer, Inc.KWS2025-09-17
00889024691629Identity HumeralZimmer, Inc.KWS2025-09-17
10885862657527EquinoxeExactech, Inc.KWS2025-09-09
10885862657534EquinoxeExactech, Inc.KWS2025-09-09
10885862657541EquinoxeExactech, Inc.KWS2025-09-09
10885862657558EquinoxeExactech, Inc.KWS2025-09-09
10885862657572EquinoxeExactech, Inc.KWS2025-09-09
10885862657602EquinoxeExactech, Inc.KWS2025-09-09
10885862657626EquinoxeExactech, Inc.KWS2025-09-09