FDA.reportPublic FDA data

Top Shelf Orthopedics

Primary DI
00850016589002
Brand
Top Shelf Orthopedics
Company
Top Shelf Manufacturing, LLC
Model
530001
Catalog number
530001
Device description
Shoulder Holder
Published
2020-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSTApparatus, Traction, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSTApparatus, Traction, Non-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850016589009PackageGS16In Commercial Distribution
00850016589002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001658900910850016589009
00850016589002008500165890028500165890020850016589002

GMDN Terms#

Term, Definition table
TermDefinition
Upper-limb traction wrap/trap, single-useA preformed device designed to encompass the fingers, hand or forearm to create a holder which can be attached to an external frame to provide traction/suspension of the upper limb during surgical procedures on the hand, arm or shoulder. It is typically made of synthetic polymer textile (e.g., nylon) and includes self-retaining fasteners (e.g., Velcro); it may be used with a traction arm band and/or malleable metal stave which acts as the anchor to the traction frame. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
866-592-0488info@topshelfortho.com

Regulatory Flags#

DUNS number
114134625
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016589187Top Shelf Orthopedics5105235105232023-05-04
00850016589194Top Shelf Orthopedics5105245105242023-05-04
00850016589200Top Shelf Orthopedics5105275105272023-05-04
00850016589217Top Shelf Orthopedics5105255105252023-05-04
00850016589224Top Shelf Orthopedics5105265105262023-05-04
00850016589408Top Shelf Orthopedics5082005082002024-03-18
00850016589415Top Shelf Orthopedics5082015082012024-03-18
00850016589422Top Shelf Orthopedics5082025082022024-03-18
00850016589460Top Shelf Orthopedics5082105082102024-03-18
00850016589477Top Shelf Orthopedics5082115082112024-03-18
00850016589484Top Shelf Orthopedics5082125082122024-03-18
00850016589019Top Shelf Orthopedics5300025300022020-12-18
00850016589026Top Shelf Orthopedics5300035300032020-12-18
00850016589033Top Shelf Orthopedics5300155300152020-12-18
00850016589040Top Shelf Orthopedics5300165300162020-12-18
10850016589009Top Shelf Orthopedics5300015300012020-12-18
10850016589016Top Shelf Orthopedics5300025300022020-12-18
10850016589023Top Shelf Orthopedics5300035300032020-12-18
10850016589030Top Shelf Orthopedics5300155300152020-12-18
10850016589047Top Shelf Orthopedics5300165300162020-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776415174MillenniumAvalign Technologies, Inc.HST2025-12-03
00842430116728TRAPEZE ARM ASSEMBLY, PATIENT HELPERMIZUHO ORTHOPEDIC SYSTEMS, INC.HST2025-07-28
00887482122723Symmetry LoganASPEN SURGICAL PRODUCTS, INC.HST2024-08-20
00615521004712ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004736ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004750ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004828ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004842ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00840277130495Innomed, Inc.INNOMED, INC.HST2024-05-09
00860011457800IHNIHN, Inc.HST2024-02-07
00860011457817IHNIHN, Inc.HST2024-02-07
10860011457807IHNIHN, Inc.HST2024-02-07
10860011457814IHNIHN, Inc.HST2024-02-07
00840277129444Innomed,Inc.INNOMED, INC.HST2023-12-19
00840277129451Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129468Innomed,Inc.INNOMED, INC.HST2023-12-19
00840277129475Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129482Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129499Innomed, Inc.INNOMED, INC.HST2023-12-19
00724995225544NASTERIS CORPORATIONHST2023-11-17
00860011173618AFTHILL LABORATORIES CO.HST2023-10-23
00860011173625Air Drop AFTHILL LABORATORIES CO.HST2023-10-23
00860001452570Air Flex IIHILL LABORATORIES CO.HST2023-10-16
04719871180167EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HST2023-08-24
04719871180365EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HST2023-08-24
00615521001490ALLENHILL-ROM, INC.HST2023-07-31
00615521001506ALLENHILL-ROM, INC.HST2023-07-31
00615521012823ALLENHILL-ROM, INC.HST2023-07-31
00615521021160ALLENHILL-ROM, INC.HST2023-07-31
00615521021177ALLENHILL-ROM, INC.HST2023-07-31