DEVICE: Shoulder Innovations Humeral Short Stem System (B1132N1HE150440)

Device Identifier (DI) Information

Shoulder Innovations Humeral Short Stem System
15mm x 44mm
In Commercial Distribution
2N1HE15044
Shoulder Innovations, Inc.
B1132N1HE150440
HIBCC

1
080404519 *Terms of Use
Shoulder Innovations - TSA - Humeral Short Stem System. Instrument. Trial Head 15mm x 44mm.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
13180 Orthopaedic prosthesis implantation positioning instrument, reusable
A 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 [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102670 000
K110905 000
K111596 000
K173824 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

b3e2b646-099d-4b3b-ab31-3c9270931f70
May 03, 2023
3
December 17, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
616-294-1026
xxx@xx.xx
CLOSE