FDA.reportPublic FDA data

Spinamic

Primary DI
08809766910187
Brand
Spinamic
Company
Value&Trust
Model
11-4600-4
Catalog number
VNTC Spinamic VSP-B11-04G
Published
2026-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTDOrthosis, Abdominal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTDOrthosis, AbdominalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809766910187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809766910187088097669101878809766910187

GMDN Terms#

Term, Definition table
TermDefinition
Multiple spinal region orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass two or more regions of the spine (e.g., sacroiliac, lumbosacral, thoracolumbosacral) to support or immobilize deformities, fractures, sprains, or strains of the spine, and may additionally provide support for the abdomen. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+82 1022867339jessica@spinamic.me

Regulatory Flags#

DUNS number
694613467
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809766910156Spinamic11-4600-3VNTC Spinamic VSP-B11-03G2026-03-18
08809766910163Spinamic11-4600-1VNTC Spinamic VSP-B11-01G2026-03-18
08809766910170Spinamic11-4600-2VNTC Spinamic VSP-B11-02G2026-03-18
08809766910194Spinamic11-4600-5VNTC Spinamic VSP-B11-05G2026-03-18
08809766910255Spinamic11-4600-0VNTC Spinamic VSP-B11-00G2026-03-18
08809766910262Spinamic11-4600-6VNTC Spinamic VSP-B11-06G2026-03-18
08809766910279Spinamic11-4600-7VNTC Spinamic VSP-B11-07G2026-03-18
08809766910286Spinamic11-4600-8VNTC Spinamic VSP-B11-08G2026-03-18
08809766910293Spinamic11-4600-9VNTC Spinamic VSP-B11-09G2026-03-18
08809766910309Spinamic25-4600-1VNTC Spinamic Replacement Pads #12026-03-18
08809766910316Spinamic25-4600-2VNTC Spinamic Replacement Pads #22026-03-18
08809766910323Spinamic25-4600-3VNTC Spinamic Replacement Pressure Plate2026-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809766910156SpinamicValue&TrustKTD2026-03-18
08809766910163SpinamicValue&TrustKTD2026-03-18
08809766910170SpinamicValue&TrustKTD2026-03-18
08809766910194SpinamicValue&TrustKTD2026-03-18
08809766910255SpinamicValue&TrustKTD2026-03-18
08809766910262SpinamicValue&TrustKTD2026-03-18
08809766910279SpinamicValue&TrustKTD2026-03-18
08809766910286SpinamicValue&TrustKTD2026-03-18
08809766910293SpinamicValue&TrustKTD2026-03-18
08809766910309SpinamicValue&TrustKTD2026-03-18
08809766910316SpinamicValue&TrustKTD2026-03-18
08809766910323SpinamicValue&TrustKTD2026-03-18
04823097716618"TM ""Rehabilitimed"" S-3M XXXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716625"TM ""Rehabilitimed"" S-3 XXXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716632"TM ""Rehabilitimed"" S-3M XXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716649"TM ""Rehabilitimed"" S-4M L Comfort"REABILITIMED TOVKTD2025-05-04
04823097716656"TM ""Rehabilitimed"" S-3 L Comfort"REABILITIMED TOVKTD2025-05-04
04823097716663"TM ""Rehabilitimed"" S-3 XL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716670"TM ""Rehabilitimed"" S-4 XXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716687"TM ""Rehabilitimed"" S-4 XL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716694"TM ""Rehabilitimed"" S-4 M Comfort"REABILITIMED TOVKTD2025-05-04
04823097716700"TM ""Rehabilitimed"" S-4 L Comfort"REABILITIMED TOVKTD2025-05-04
04823097716717"TM ""Rehabilitimed"" S-4 XXXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716724"TM ""Rehabilitimed"" S-3 M Comfort"REABILITIMED TOVKTD2025-05-04
04823097716731"TM ""Rehabilitimed"" S-4M M Comfort"REABILITIMED TOVKTD2025-05-04
04823097716748"TM ""Rehabilitimed"" S-3M L Comfort"REABILITIMED TOVKTD2025-05-04
04823097716755"TM ""Rehabilitimed"" S-4M XXXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716762"TM ""Rehabilitimed"" S-3M XL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716779"TM ""Rehabilitimed"" S-4M XXL Comfort"REABILITIMED TOVKTD2025-05-04
04823097716786"TM ""Rehabilitimed"" S-3M M Comfort"REABILITIMED TOVKTD2025-05-04