DEVICE: Titanium-TSY™ Shoulder Plate (00813892020762)
Device Identifier (DI) Information
Titanium-TSY™ Shoulder Plate
TSP-140
In Commercial Distribution
TSP-140
Orthopedic Sciences Inc
TSP-140
In Commercial Distribution
TSP-140
Orthopedic Sciences Inc
140° Titanium-TSY™ Shoulder Plate
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
61688 | Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile |
A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRS | PLATE, FIXATION, BONE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K063033 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep at room temperature |
Storage Environment Temperature: between 0 and 122 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Angle: 140 degree |
Device Record Status
439d5821-b08e-4bc1-9e87-6c9a5e6a7f12
February 19, 2024
4
October 13, 2015
February 19, 2024
4
October 13, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(562)799-5550
3053
info@orthopedicsciences.com
info@orthopedicsciences.com