FDA.reportPublic FDA data

Top Shelf Orthopedics

Primary DI
10850016589023
Brand
Top Shelf Orthopedics
Company
Top Shelf Manufacturing, LLC
Model
530003
Catalog number
530003
Published
2020-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
10850016589023PackageGS16In Commercial Distribution
00850016589026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001658902310850016589023
00850016589026008500165890268500165890260850016589026

GMDN Terms#

Term, Definition table
TermDefinition
Upper-limb traction wrap/trap, single-use, sterileA sterile 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
114134625
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
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
00850016589002Top Shelf Orthopedics5300015300012020-12-18
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
10850016589030Top Shelf Orthopedics5300155300152020-12-18
10850016589047Top Shelf Orthopedics5300165300162020-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00844107000804QuikBow Arbutus Medical IncKQZ2026-04-28
00848340016806ALLENHILL-ROM, INC.KQZ2026-04-24
00888867484986Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485099Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485105Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485112Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867484983Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485096Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485102Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485119Arthrex®ARTHREX, INC.KQZ2025-12-10
00810075281521BoneFoamBONE FOAM, INC.KQZ2025-08-15
00810075281491BoneFoamBONE FOAM, INC.KQZ2025-08-15
00810075281514BoneFoamBONE FOAM, INC.KQZ2025-08-15
00888867502710Arthrex®ARTHREX, INC.KQZ2025-08-14
10888867502717Arthrex®ARTHREX, INC.KQZ2025-08-14
20845854082925Paradigm RevolutionConmed CorporationKQZ2023-06-13
20845854082932Paradigm RevolutionConmed CorporationKQZ2023-06-13
0078755101165490403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
00787551011678NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
2078755101165890403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
20787551011672NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
00816342020718Accessories, arthroscopicPARCUS MEDICAL LLCKQZ2022-12-06
00842331141027Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331143373Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331136627Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-10
00610570001712"100 FT. 3/16"" TRACTION CORD"Bird & Cronin, LLCKQZ2022-08-20
00610570001750"1500 FT. 3/16"" TRACTION CORD"Bird & Cronin, LLCKQZ2022-08-20
00610570006588BUCKS BOOT XSBird & Cronin, LLCKQZ2022-08-20
00610570006595BUCKS BOOT SMBird & Cronin, LLCKQZ2022-08-20
00610570006601BUCKS BOOT MDBird & Cronin, LLCKQZ2022-08-20