DEVICE: M-Brace Air (05391512281885)
Device Identifier (DI) Information
M-Brace Air
43 L
In Commercial Distribution
43
INDACO SRL
43 L
In Commercial Distribution
43
INDACO SRL
The Vega Aligner #43 knee brace with Range of motion (ROM) is designed to stabilize the motion of the knee joint, keeping it aligned during flexion and extension movements. Constructed entirely from breathable materials, the next-to-skin layer is made from anti-bacterial and anti-allergy fabric. Its complex structure, equipped with patella stabilizer, offers comfortable containment of the patellar compartment, useful in cases of associated conditions (medial or lateral ligaments, anterior or posterior cruciate ligament and patellar instability). Two patented, multicentric, adjustable aluminum rods are included to control flexion and extension quickly and easily. The rods are equipped with bearings supporting the condyles and rigid tibial and femoral supports to control rotation. L1832 or L1833 approved.
INDICATIONS
A knee orthosis with adjustable knee joints used for:
• Patellar chonodropathy (osteochondral repairs)
• Retropatellar osteoarthitis
• Post-operative and post-traumatic irritations including rehabilitation of: MCL, LCL, PCL, ACL (Sprains, Meniscus injuries, Lateral, Anterior, Medial & Posterior tilt, etc.)
• Post lateral release surgery to limit the extension and flexion of the joint
• Patella and knee instabilities (Patella Dislocation, Patella Subluxation, Patella Alta, Patella stabilization, Patella tendon repairs)
• General knee pain
• Mild Chondromalacia
• Condylar Fractures
• Tibial Plateau Fractures
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
41065 | Knee support orthosis |
A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ITQ | Joint, Knee, External Brace |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
372a0b3d-4e42-456a-a36b-1bbc21ee12e2
February 21, 2024
1
February 13, 2024
February 21, 2024
1
February 13, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05391512286699 | 6 | 05391512281885 | In Commercial Distribution | Box Case |
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
[?]
1-866-374-4050
contact@m-brace.com
contact@m-brace.com