DEVICE: PediLoc Tibia (00841132135464)
Device Identifier (DI) Information
PediLoc Tibia
00-0903-6201
In Commercial Distribution
00-0903-6201
ORTHOPEDIATRICS CORP.
00-0903-6201
In Commercial Distribution
00-0903-6201
ORTHOPEDIATRICS CORP.
3.5MM NARROW MEDIAL DISTAL TIBIAL COMPRESSION PLATE, 1 HOLE PLATE RIGHT
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
44896 | Growth-correction orthopaedic fixation plate kit |
A collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRS | Plate, fixation, bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K100240 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
194e82ff-5fab-48a5-8fe2-4f92511bff42
February 19, 2024
4
February 15, 2017
February 19, 2024
4
February 15, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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(574)268-6379
Rbremer@orthopediatrics.com
Rbremer@orthopediatrics.com