FDA.reportPublic FDA data

Tahoe Unicompartmental Knee System

Primary DI
00840286860420
Brand
Tahoe Unicompartmental Knee System
Company
Shalby Advanced Technologies, Inc.
Model
3000-1-0064
Catalog number
3000-1-0064
Device description
TUKS, TIBIAL KEEL PICK, CLR, LONG
Published
2026-07-10
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
HTPFile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTPFileOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286860420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286860420008402868604208402868604200840286860420

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
00840286860147Tahoe Unicompartmental Knee System3000-0-17013000-0-17012026-07-10
00840286860154Tahoe Unicompartmental Knee System3000-0-17023000-0-17022026-07-10
00840286860161Tahoe Unicompartmental Knee System3000-0-17033000-0-17032026-07-10
00840286860178Tahoe Unicompartmental Knee System3000-0-17043000-0-17042026-07-10
00840286860185Tahoe Unicompartmental Knee System3000-0-17053000-0-17052026-07-10
00840286860192Tahoe Unicompartmental Knee System3000-0-17063000-0-17062026-07-10
00840286860208Tahoe Unicompartmental Knee System3000-0-17073000-0-17072026-07-10
00840286860215Tahoe Unicompartmental Knee System3000-0-17083000-0-17082026-07-10
00840286860239Tahoe Unicompartmental Knee System3000-0-16023000-0-16022026-07-10
00840286860246Tahoe Unicompartmental Knee System3000-0-16033000-0-16032026-07-10
00840286860253Tahoe Unicompartmental Knee System3000-0-16043000-0-16042026-07-10
00840286860260Tahoe Unicompartmental Knee System3000-0-16053000-0-16052026-07-10
00840286860277Tahoe Unicompartmental Knee System3000-0-16063000-0-16062026-07-10
00840286860284Tahoe Unicompartmental Knee System3000-0-16073000-0-16072026-07-10
00840286860291Tahoe Unicompartmental Knee System3000-0-16083000-0-16082026-07-10
00840286860307Tahoe Unicompartmental Knee System3600-0-00003600-0-00002026-07-10
00840286860314Tahoe Unicompartmental Knee System3600-0-00013600-0-00012026-07-10
00840286860321Tahoe Unicompartmental Knee System3600-0-00023600-0-00022026-07-10
00840286860338Tahoe Unicompartmental Knee System3600-0-00033600-0-00032026-07-10
00840286860345Tahoe Unicompartmental Knee System3600-0-00043600-0-00042026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286860413Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HTP2026-07-09
008401944974973P Small-Mini Frag SystemORTHOPEDIATRICS CORP.HTP2026-06-10
10810128463574Rasp Up Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2026-05-13
10810128463581Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2026-05-13
06974940306642endophixSuzhou Endophix Co., Ltd.HTP2025-12-12
10818674026618Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
10818674026625Rasp Up Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
04047844052501INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844067390INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844099742INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844101117INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844101155INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844126998INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
00840286841955Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853965Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853972Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286841009TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-21
00840286855990TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856003TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856010TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856027TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856034TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840124518742FuzeFix MiniFUSION ORTHOPEDICS, LLCHTP2025-05-13
04047844059852INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-05-09
04046826034801MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHTP2025-05-07
04047844058442INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-05-05
04047844058558RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058565RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058572RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058589RABEASIGNUS Medizintechnik GmbHHTP2025-03-12