Primary Device ID | B1132N1HE150440 |
NIH Device Record Key | b3e2b646-099d-4b3b-ab31-3c9270931f70 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Shoulder Innovations Humeral Short Stem System |
Version Model Number | 15mm x 44mm |
Catalog Number | 2N1HE15044 |
Company DUNS | 080404519 |
Company Name | SHOULDER INNOVATIONS, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx | |
Phone | 616-294-1026 |
xxx@xx.xx |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B1132N1HE150440 [Primary] |
MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
[B1132N1HE150440]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-01-17 |
Device Publish Date | 2018-12-17 |
B1132N2SN064401 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 44mm x 6mm. |
B1132N2SN063801 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 38mm x 6mm. |
B1132N2SN063201 | Shoulder Innovations - TSA - Humeral Short Stem System. Titanium short stem. 32 mm x 6mm. |
B1132N2HE210561 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 56mm Diamete |
B1132N2HE210521 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 52mm Diamete |
B1132N2HE210481 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 48mm Diamete |
B1132N2HE210441 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 21mm High x 44mm Diamete |
B1132N2HE180561 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 56mm Diamete |
B1132N2HE180521 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 52mm Diamete |
B1132N2HE180481 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 48mm Diamete |
B1132N2HE180441 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 44mm Diamete |
B1132N2HE180401 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 18mm High x 40mm Diamete |
B1132N2HE150521 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 52mm Diamete |
B1132N2HE150481 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 48mm Diamete |
B1132N2HE150441 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 44mm Diameter |
B1132N2HE150401 | Shoulder Innovations - TSA - Humeral Short Stem System. Humeral Head. 15mm High x 40mm Diamete |
B1132N1IZ000560 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Sizer Disk. 56mm. |
B1132N1IZ000520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Sizer Disk - 52mm |
B1132N1IZ000480 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Sizer Disk. 48mm. |
B1132N1IZ000440 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Sizer Disk. 44mm. |
B1132N1IZ000400 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Sizer Disk - 40mm |
B1132N1IV000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Version Control. |
B1132N1IT000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Multi-Use Tool. |
B1132N1IS000010 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Screwdriver. |
B1132N1IR00000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Stem Drill |
B1132N1IP000560 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Cut Protector - 56 |
B1132N1IP000520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Cut Protector - 52 |
B1132N1IP000480 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Cut Protector - 48 |
B1132N1IP000440 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Cut Protector - 44m |
B1132N1IP000400 | Shoulder Innovations - TSA - Humeral Short Stem. Instrument. Humeral Cut Protector - 40 mm. |
B1132N1IM000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Impaction Stand |
B1132N1IJ000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Broach Impactor Handle. |
B1132N1IH000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Impactor |
B1132N1IG000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Inspection Gauge. |
B1132N1IF000610 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Calcar Planar - 61mm |
B1132N1IF000530 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Calcar Planar - 53mm. |
B1132N1IF000450 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Calcar Planar- 45mm. |
B1132N1IE000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Gauge. |
B1132N1ID000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Distractor |
B1132N1IA000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument - 2D Humeral Cut Guide |
B1132N1HI000000 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial Insert. |
B1132N1HE210560 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm |
B1132N1HE210520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm |
B1132N1HE210480 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mmx |
B1132N1HE210440 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 21mm |
B1132N1HE180520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 18mm |
B1132N1HE180480 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Trial Head. 18mm |
B1132N1HE180440 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 18mm x |
B1132N1HE180400 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 18mm x |
B1132N1HE150520 | Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Humeral Head Trial. 15mm |