DEVICE: FREE GLIDING SCFE SCREW SYSTEM (07540194002549)

Device Identifier (DI) Information

FREE GLIDING SCFE SCREW SYSTEM
SCF-F73-88S/90L
In Commercial Distribution
SCF-F73-88S/90L
Pega Medical Inc
07540194002549
GS1

1
257315713 *Terms of Use
Female Component 88/90mm Ø7.3mm
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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
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FDA Product Code

[?]
Product Code Product Code Name
HWC Screw, fixation, bone
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K131591 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: keep at room temperature
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Clinically Relevant Size

[?]
Size Type Text
Length: 88 Millimeter
Outer Diameter: 7.3 Millimeter
Length: 90 Millimeter
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Device Record Status

c59cb94f-2bbe-41a1-a5fa-609d32f2069e
February 19, 2024
4
October 20, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(450)688-5144 242
egarcia@pegamedical.com
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