Shoulder Innovations Inset Reverse Total Shoulder 2R2HB42006

GUDID B1132R2HB420060

Shoulder Innovations Inset Reverse Total Shoulder - RSA Offset Bearing Trial 42 x 6mm

Shoulder Innovations, Inc.

Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis Total shoulder prosthesis
Primary Device IDB1132R2HB420060
NIH Device Record Key8d64fd4c-2826-419e-b5a5-1846dd631f3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameShoulder Innovations Inset Reverse Total Shoulder
Version Model NumberRSA Offset Bearing Trial 342 x 6mm
Catalog Number2R2HB42006
Company DUNS080404519
Company NameShoulder Innovations, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com
Phone616.294.1026
Emailinfo@shoulderinnovations.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1132R2HB420060 [Primary]

FDA Product Code

MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


[B1132R2HB420060]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-06
Device Publish Date2021-08-29

On-Brand Devices [Shoulder Innovations Inset Reverse Total Shoulder]

B1132R1P1203390Shoulder Innovations Inset Reverse Total Shoulder - Offset Humeral Bearing - 39mm Diameter, +3 m
B1132R1P1203360Shoulder Innovations Inset Reverse Total Shoulder - Offset Humeral Bearing - 36mm Diameter, +3 m
B1132R1P1203330Shoulder Innovations Inset Reverse Total Shoulder - Offset Humeral Bearing - 33mm Diameter, +3 m
B1132R1P1000390Shoulder Innovations Inset Reverse Total Shoulder - Neutral Humeral Bearing - 39mm Diameter, 0 m
B1132R1P1000360Shoulder Innovations Inset Reverse Total Shoulder - Neutral Humeral Bearing - 36mm Diameter, 0 m
B1132R1P1000330Shoulder Innovations Inset Reverse Total Shoulder - Neutral Humeral Bearing - 33mm Diameter, 0 m
B1132R1M3806010Shoulder Innovations Inset Reverse Total Shoulder - Humeral Tray. 38mm x 6mm.
B1132R1M3800010Shoulder Innovations Inset Reverse Total Shoulder - Humeral Tray. 38mm x 0mm. Titanium
B1132R1GSC00420Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 42mm x 0mm x 0mm.
B1132R1GSC00390Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 39mm x 0mm x 0mm.
B1132R1GSC00360Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x 0mm.
B1132R1GSC00330Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 33mm x 0mm x 0mm.
B1132R1GLC06420Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 42mm x 0mm x +63mm.
B1132R1GLC06390Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 39mm x 0mm x +6mm.
B1132R1GLC06360Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x +6mm.
B1132R1GLC03420Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 42mm x 0mm x +3mm.
B1132R1GLC03390Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 39mm x 0mm x +3mm.
B1132R1GLC03360Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 36mm x 0mm x +3mm.
B1132R1GLC03330Shoulder Innovations Inset Reverse Total Shoulder - Standard Glenosphere 33mm x 0mm x +3mm.
B1132R1R2715250Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 15 degree
B1132R1R2715150Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 15 degree
B1132R1R2710250Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 10 degree
B1132R1R2710150Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 10 degree
B1132R1R2705250Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 5 degree,
B1132R1R2705150Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 5 degree,
B1132R1R2700250Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 0 degree,
B1132R1R2700150Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 27mm Diameter, 0 degree,
B1132R1R2415250Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 15 degree
B1132R1R2415150Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 15 degree
B1132R1R2410250Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 10 degree
B1132R1R2410150Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 10 degree
B1132R1R2405250Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 5 degree,
B1132R1R2405150Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 5 degree,
B1132R1R2400250Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 0 degree,
B1132R1R2400150Shoulder Innovations Inset Reverse Total Shoulder - Glenoid Baseplate - 24mm Diameter, 0 degree,
B1132R1P1505390Shoulder Innovations Inset Reverse Total Shoulder - Face Changing Humeral Bearing - 39mm Diamete
B1132R1P1505360Shoulder Innovations Inset Reverse Total Shoulder - Face Changing Humeral Bearing - 36mm Diamete
B1132R1P1505330Shoulder Innovations Inset Reverse Total Shoulder - Face Changing Humeral Bearing - 33mm Diamete
B1132R1GN516420Shoulder Innovations Inset Reverse Total Shoulder - RSA Baseplate Set Screw Locking Nut (Long)
B1132R1GN516410Shoulder Innovations Inset Reverse Total Shoulder - RSA Locking Nut/Set Screw (Medium)
B1132R1GB407260Shoulder Innovations Inset Reverse Total Shoulder - Glenosphere Locking Bolt - Medium/Long
B1132R1GB407200Shoulder Innovations Inset Reverse Total Shoulder - Glenosphere Locking Bolt STD-ECC
B1132R2HR350020Shoulder Innovations Inset Reverse Total Shoulder - RSA Humeral Reamer Guide Post
B1132R2HR350000Shoulder Innovations Inset Reverse Total Shoulder - RSA Humeral Convex Reamer
B1132R2HI000300Shoulder Innovations Inset Reverse Total Shoulder - RSA Offset Twistlock Base Assembly
B1132R2HI000200Shoulder Innovations Inset Reverse Total Shoulder - RSA Offset Twistlock T-Handle Assembly
B1132R2HC100030Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Caddy Lid
B1132R2HC100020Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Caddy
B1132R2HC100010Shoulder Innovations Inset Reverse Total Shoulder - RSA Tray
B1132R2HC100000Shoulder Innovations Inset Reverse Total Shoulder - RSA Case Base

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.