DEVICE: osteo-WEDGE 2.5mm x 10mm Locking Bone Screw (M621OW25LBS10MM0)
Device Identifier (DI) Information
osteo-WEDGE 2.5mm x 10mm Locking Bone Screw
GM-200-10
In Commercial Distribution
OW2.5LBS-10MM
Gramedica
GM-200-10
In Commercial Distribution
OW2.5LBS-10MM
Gramedica
osteo-WEDGE 2.5mm x 10mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
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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? |
---|---|---|---|---|
61689 | Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile |
A non-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. This device is intended to be sterilized prior to use.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HWC | Screw, Fixation, Bone |
HRS | Plate, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K111326 | 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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Device Size Text, specify: 2.5mm x 10mm |
Device Record Status
a4da023a-632f-4c36-bf64-d5b3e66a4273
February 19, 2024
5
February 14, 2017
February 19, 2024
5
February 14, 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
[?]
586-677-9600
xx@xx.xx
xx@xx.xx