FDA.reportPublic FDA data

D.B.S. Dynamic Brace System

Primary DI
07290015711302
Brand
D.B.S. Dynamic Brace System
Company
MEDITRAC LTD.
Model
DBS1
Device description
The DBS (Dynamic Brace System) is an accessory to the Vertetrac, intended for the treatment of scoliosis.Idiopathic scoliosis (juvenile, adolescent, or adult)
Published
2022-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KQZComponent, Traction, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015711302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015711302072900157113027290015711302

GMDN Terms#

Term, Definition table
TermDefinition
Wearable lumbar spine traction deviceAn externally-worn orthopaedic device designed to apply traction to the lumbar spine to relieve symptoms of back pain and sciatica. It consists of adjustable components worn superiorly under the rib cage, and inferiorly over the iliac crests, with rods holding the components apart that can be adjusted to apply traction forces by separation. It may include an additional attachable component intended for the treatment of scoliosis. It is intended for use in the home or a clinical setting. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514587369
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015711104VertetracVERT92022-07-25
07290015711203Cervico2000CERV82022-07-25

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Primary DI, Brand, Company table
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00610570006588BUCKS BOOT XSBird & Cronin, LLCKQZ2022-08-20
00610570006595BUCKS BOOT SMBird & Cronin, LLCKQZ2022-08-20
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