FDA.reportPublic FDA data

Ortho Trax System (cart priced separately).

Primary DI
10841736112202
Brand
Ortho Trax System (cart priced separately).
Company
SKYTRON LLC
Model
6990
Device description
Ortho Trax System (cart priced separately).
Published
2019-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQOTable, Operating-Room, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841736112202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173611220210841736112202

GMDN Terms#

Term, Definition table
TermDefinition
Operating table orthopaedic extensionAn orthopaedic device intended to function as a freestanding framework or that can be attached to an operating table or table top to provide additional support to a patient's body segment or part during orthopaedic surgical procedures (e.g., lower trunk for traction of the legs, upper body during shoulder surgery). It typically consists of height, length and angle adjustable supports or telescopic bars/plates.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-759-8766info@skytron.us

Regulatory Flags#

DUNS number
078375583
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736124410Skytron 200 x 400 VESA Adapter Plate4A-VESA-200-400 Freedom4A-VESA-200-4002026-03-19
10841736125141CleanStartCSTART-7115CSTART-71152025-12-19
10841736125158CleanStartCSTART-7130CSTART-71302025-12-19
10841736125165CleanStartCSTART-8115CSTART-81152025-12-19
10841736125172CleanStartCSTART-8130CSTART-81302025-12-19
10841736125189CleanStartCSTART-8315CSTART-83152025-12-19
10841736125196CleanStartCSTART-8330CSTART-83302025-12-19
10841736125202CleanStartCSTART-9815CSTART-98152025-12-19
10841736125219CleanStartCSTART-9830CSTART-98302025-12-19
10841736124298Skytron LLC40-LC-ED40-LC-ED2025-12-09
10841736124427Sterling 1000-MIS-WA1000-MIS-WA2025-12-09
10841736124434Sterling 1800-MIS-WA1800-MIS-WA2025-12-09
10841736124861Skytron4-030-42-94-030-42-92025-12-03
10841736124878Skytron1-012-04-21-012-04-22025-12-03
10841736124885Skytron1-012-04-31-012-04-32025-12-03
10841736124892Skytron1-012-04-41-012-04-42025-12-03
10841736124908Skytron1-012-04-51-012-04-52025-12-03
10841736124915Skytron2-060-05-3S2-060-05-3S2025-12-03
10841736124939Skytron4-030-01-14-030-01-12025-12-03
10841736124946Skytron4-030-10-2WS4-030-10-2WS2025-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995232016NASTERIS CORPORATIONFQO2026-05-26
00724995232023NASTERIS CORPORATIONFQO2026-05-26
00724995232054NASTERIS CORPORATIONFQO2026-05-26
00724995232061NASTERIS CORPORATIONFQO2026-05-26
00724995232078NASTERIS CORPORATIONFQO2026-05-26
10841736124410Skytron 200 x 400 VESA Adapter PlateSKYTRON LLCFQO2026-03-19
04061591001032MultibarOndal Medical Systems GmbHFQO2026-02-02
00190376678665ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678689ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678764ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678771ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678795ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678801ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678818ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678825ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678832ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
10841736124298Skytron LLCSKYTRON LLCFQO2025-12-09
10841736124861SkytronSKYTRON LLCFQO2025-12-03
10841736125226SkytronSKYTRON LLCFQO2025-12-03
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06948350528895MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528901MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528918MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528925MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528932MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22
06948350528949MindrayNanjing Mindray Bio-Medical Electronics Co.,LtdFQO2025-09-22