DEVICE: M-Brace Air (05391512281885)

Device Identifier (DI) Information

M-Brace Air
43 L
In Commercial Distribution
43
INDACO SRL
05391512281885
GS1

1
338470646 *Terms of Use
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
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
Yes
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?
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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ITQ Joint, Knee, External Brace
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

372a0b3d-4e42-456a-a36b-1bbc21ee12e2
February 21, 2024
1
February 13, 2024
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-866-374-4050
contact@m-brace.com
CLOSE