DEVICE: FREE GLIDING SCFE SCREW SYSTEM (07540194002471)
Device Identifier (DI) Information
FREE GLIDING SCFE SCREW SYSTEM
SCF-F73-60S/62L
In Commercial Distribution
SCF-F73-60S/62L
Pega Medical Inc
SCF-F73-60S/62L
In Commercial Distribution
SCF-F73-60S/62L
Pega Medical Inc
Female Component 60/62mm Ø7.3mm
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? |
---|---|---|---|---|
56642 | Orthopaedic bone screw, non-bioabsorbable, non-sterile |
A small, non-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). Screws available are: 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. This device must be sterilized prior to use.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWC | Screw, fixation, bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131591 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: keep at room temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 62 Millimeter |
Outer Diameter: 7.3 Millimeter |
Length: 60 Millimeter |
Device Record Status
2a22e88f-9d7b-4552-ac44-4ddc159b0af1
February 19, 2024
4
October 20, 2016
February 19, 2024
4
October 20, 2016
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 |
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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(450)688-5144
242
egarcia@pegamedical.com
egarcia@pegamedical.com