DEVICE: TELEGRAPH® EVOLUTION Humeral Nailing System (03661489707698)
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Device Identifier (DI) Information
TELEGRAPH® EVOLUTION Humeral Nailing System
270769 - TELEGRAPH EVOLUTION CANNULATED HUMERAL NAIL LONG RIGHT D7 L210
In Commercial Distribution
FOURNITURES HOSPITALIERES INDUSTRIE
270769 - TELEGRAPH EVOLUTION CANNULATED HUMERAL NAIL LONG RIGHT D7 L210
In Commercial Distribution
FOURNITURES HOSPITALIERES INDUSTRIE
No description.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
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| 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? |
|---|---|---|---|---|
| 38153 | Humerus intramedullary nail |
A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the humerus to immobilize the ends of a fractured bone in position to promote healing; it may also be used to support the bone in the presence of a pathological condition. It may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.
|
Active | true |
| 46646 | Orthopaedic bone screw, non-bioabsorbable, sterile |
A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.
|
Obsolete | false |
| 61671 | Orthopaedic bone washer, sterile |
A sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.
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Obsolete | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K200127 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
2ceea507-9522-4190-ab62-177bdac34287
February 06, 2025
4
November 20, 2020
February 06, 2025
4
November 20, 2020
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
[?]
No Customer Contact currently defined