DEVICE: TS-Bone Hip Plate (00813892020014)
Device Identifier (DI) Information
TS-Bone Hip Plate
PDT-130
In Commercial Distribution
PDT-130
Orthopedic Sciences Inc
PDT-130
In Commercial Distribution
PDT-130
Orthopedic Sciences Inc
130° Titanium TS-Bone Hip 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 [?] |
---|---|
K063709 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 122 Degrees Fahrenheit |
Special Storage Condition, Specify: Keep at room temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Angle: 130 degree |
Device Record Status
a79ba583-4c9f-43f9-81b3-c854743d53cd
February 19, 2024
4
September 28, 2015
February 19, 2024
4
September 28, 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