FDA.reportPublic FDA data

Tahoe Unicompartmental Knee System

Primary DI
00840286860390
Brand
Tahoe Unicompartmental Knee System
Company
Shalby Advanced Technologies, Inc.
Model
3000-0-0062
Catalog number
3000-0-0062
Device description
TUKS, TIBIAL FIXATION PIN, THREADED, 3.2MM
Published
2026-07-09
Public version status
New
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
GFCDriver, Surgical, Pin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFCDriver, Surgical, PinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286860390PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286860390008402868603908402868603900840286860390

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, reusableA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100khansen@shalby.us

Regulatory Flags#

DUNS number
085976260
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286853163TaperSet Hip System1911-3-10751911-3-10752026-07-09
00840286853170TaperSet Hip System1911-3-11051911-3-11052026-07-09
00840286853187TaperSet Hip System1911-3-11351911-3-11352026-07-09
00840286855587TaperSet Hip System1911-3-11651911-3-11652026-07-09
00840286855921TaperSet Hip System1911-3-12101911-3-12102026-07-09
00840286859929TaperSet Hip System1911-3-10501911-3-10502026-07-09
00840286859943TaperSet Hip System1910-3-10751910-3-10752026-07-09
00840286859967TaperSet Hip System1910-3-11051910-3-11052026-07-09
00840286859974TaperSet Hip System1910-3-11351910-3-11352026-07-09
00840286859981TaperSet Hip System1910-3-11651910-3-11652026-07-09
00840286859998TaperSet Hip System1910-3-12101910-3-12102026-07-09
00840286860000TaperSet Hip System1910-3-10501910-3-10502026-07-09
00840286860086Consensus Knee System55088-0055088-002026-07-09
00840286860093Tahoe Unicompartmental Knee System3000-0-01093000-0-01092026-07-09
00840286860109Tahoe Unicompartmental Knee System3000-0-00753000-0-00752026-07-09
00840286860116Tahoe Unicompartmental Knee System3000-0-00723000-0-00722026-07-09
00840286860123Tahoe Unicompartmental Knee System3000-0-00693000-0-00692026-07-09
00840286860130Tahoe Unicompartmental Knee System3000-0-00703000-0-00702026-07-09
00840286860222Tahoe Unicompartmental Knee System3000-0-16013000-0-16012026-07-09
00840286860406Tahoe Unicompartmental Knee System3000-0-00633000-0-00632026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663108645Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCGFC2025-11-12
00842188130304K-WiresTrimed, INC.GFC2025-07-08
00841132197066PediNailORTHOPEDIATRICS CORP.GFC2025-06-05
00840194472401PNP FemurORTHOPEDIATRICS CORP.GFC2025-05-28
00840286842129Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286842136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286846714Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855044Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855051Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855068Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855136Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855143Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855150Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286855167Consensus Knee System/Revision Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286859950Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-22
00840286843867UniSyn Hip SystemShalby Advanced Technologies, Inc.GFC2025-05-20
14053613292136PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292143PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292150PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613292167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-19
14053613293164PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
04053613293167PIN DRIVERGebr. Brasseler GmbH & Co. KGGFC2025-05-15
00840286846707Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.GFC2025-05-14
04042409452987NAaap Implantate AGGFC2025-02-26
04042409453007NAaap Implantate AGGFC2025-02-26
04042409453021NAaap Implantate AGGFC2025-02-26
04042409453045NAaap Implantate AGGFC2025-02-26
00860007230059Insurgical, Inc.Insurgical, Inc.GFC2025-01-17
00860007230066Insurgical, Inc.Insurgical, Inc.GFC2025-01-17
10886982347459NASynthes GmbHGFC2024-08-14