Tahoe Unicompartmental Knee System

TUKS, Tibial Cut Block, Noncaptured, RM/LL, Extra Patella CLR, ASSY

Registry build 21.09.26
21manufacturers in China registered for this device type
137catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (10), Shanghai (3), Zhejiang (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code HWT
Manufacturer City Province Registered as Device types
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Canwell Medical Co., Ltd. Jinhua Zhejiang Contract manufacturer 42
Suzhou Elite Precision Machinery Co., Ltd. Kunshan Jiangsu Contract manufacturer 35
Xinhua Healthcare Industry Co., Limited Zibo Shandong Contract manufacturer 30
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
B-ONE Medical (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 23
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5
Guangzhou Clean Medical Products Manufacturing Corp Guangzhou Guangdong Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235

Showing 12 of 21. All 21 manufacturers in China registered for Template

Record

Regulatory record for Tahoe Unicompartmental Knee System
Listed by Shalby Advanced Technologies, Inc., United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Establishment Contract manufacturer, Contract steriliser, Manufacturer
Premarket notification Exempt
Record published 2025-05-22

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Tahoe Unicompartmental Knee System
Catalogue number Size Status
3603-0-0107 Tibial Prep Guide, Chisel, Sharp, Press, Dual Ended, Sz 7 In distribution
3260-1-0007 TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 7 In distribution
3000-1-1701 Femoral Drill Guide, Anterior paddle; Med/Lat, Size 1 In distribution
3600-0-0003 In distribution
3000-0-1705 In distribution
3000-0-1701 In distribution
3601-0-0001 In distribution
3602-0-0006 In distribution
3601-0-0005 In distribution
3000-0-0910 Spacer Block, Stepped, 9mm/10mm In distribution
3603-0-0106 Tibial Prep Guide, Chisel, Sharp, Press, Dual Ended, Sz 6 In distribution
3602-0-0007 In distribution
3060-0-0013 Trial, Tibial Insert, Size 0, 13mm In distribution
3060-0-1212 Trial, Tibial Insert, Size 1/2, 12mm In distribution
3260-1-0008 TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 8 In distribution
3000-1-1607 FEMORAL SIZER, CTR HANDLE, SIZE 7 In distribution
3060-0-3412 Trial, Tibial Insert, Size 3/4, 12mm In distribution
3060-0-5610 Trial, Tibial Insert, Size 5/6, 10mm In distribution
3000-1-1604 FEMORAL SIZER, CTR HANDLE, SIZE 4 In distribution
3060-0-7813 Trial, Tibial Insert, Size 7/8, 13mm In distribution
3060-0-7812 Trial, Tibial Insert, Size 7/8, 12mm In distribution
3060-0-0010 Trial, Tibial Insert, Size 0, 10mm In distribution
3000-0-1604 In distribution
3600-0-0008 In distribution
3000-1-1702 Femoral Drill Guide, Anterior paddle; Med/Lat, Size 2 In distribution
3060-0-1213 Trial, Tibial Insert, Size 1/2, 13mm In distribution
3000-0-1314 Spacer Block, Stepped, 13mm/14mm In distribution
3060-0-3413 Trial, Tibial Insert, Size 3/4, 13mm In distribution
3060-0-3411 Trial, Tibial Insert, Size 3/4, 11mm In distribution
3600-0-0007 In distribution
3060-0-5608 Trial, Tibial Insert, Size 5/6, 8mm In distribution
3060-0-0008 Trial, Tibial Insert, Size 0, 8mm In distribution
3060-0-5614 Trial, Tibial Insert, Size 5/6, 14mm In distribution
3000-1-1517 FEMORAL CUT BLOCK, NON-CAPTURED, OFFSET CUTOUT, SIZE 7 In distribution
3000-1-1602 FEMORAL SIZER, CTR HANDLE, SIZE 2 In distribution
3601-0-0002 In distribution
3260-0-0006 In distribution
3000-0-1605 In distribution
3260-1-0003 TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 3 In distribution
3000-0-1112 Spacer Block, Stepped, 11mm/12mm In distribution
3602-0-0001 In distribution
3000-0-1603 In distribution
3260-0-0004 In distribution
3600-0-0002 In distribution
3060-0-0014 Trial, Tibial Insert, Size 0, 14mm In distribution
3603-0-0105 Tibial Prep Guide, Chisel, Sharp, Press, Dual Ended, Sz 5 In distribution
3060-0-3410 Trial, Tibial Insert, Size 3/4, 10mm In distribution
3060-0-5612 Trial, Tibial Insert, Size 5/6, 12mm In distribution
3060-0-0011 Trial, Tibial Insert, Size 0, 11mm In distribution
3060-0-7810 Trial, Tibial Insert, Size 7/8, 10mm In distribution
3603-0-0100 Tibial Prep Guide, Chisel, Sharp, Press, Dual Ended, Sz 0 In distribution
3000-1-1514 FEMORAL CUT BLOCK, NON-CAPTURED, OFFSET CUTOUT, SIZE 4 In distribution
3060-0-1209 Trial, Tibial Insert, Size 1/2, 9mm In distribution
3060-0-1208 Trial, Tibial Insert, Size 1/2, 8mm In distribution
3260-0-0005 In distribution
3601-0-0003 In distribution
3000-1-1608 FEMORAL SIZER, CTR HANDLE, SIZE 8 In distribution
3260-0-0008 In distribution
3000-0-1607 In distribution
3600-0-0006 In distribution
3601-0-0000 In distribution
3000-0-1703 In distribution
3260-1-0005 TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 5 In distribution
3000-0-1608 In distribution
3000-1-0069 Tibial Cut Block, Noncaptured, RM/LL, Extra Patella CLR, ASSY In distribution
3000-1-1706 Femoral Drill Guide, Anterior paddle; Med/Lat, Size 6 In distribution
3000-0-1601 In distribution
3000-0-0069 In distribution
3603-0-0102 Tibial Prep Guide, Chisel, Sharp, Press, Dual Ended, Sz 2 In distribution
3060-0-3409 Trial, Tibial Insert, Size 3/4, 9mm In distribution
3000-0-1707 In distribution
3000-0-0008 Spacer Block, 8mm In distribution
3602-0-0002 In distribution
3600-0-0000 In distribution
3000-1-1512 FEMORAL CUT BLOCK, NON-CAPTURED, OFFSET CUTOUT, SIZE 2 In distribution
3000-1-1705 Femoral Drill Guide, Anterior paddle; Med/Lat, Size 5 In distribution
3260-1-0006 TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 6 In distribution
3000-1-1708 Femoral Drill Guide, Anterior paddle; Med/Lat, Size 8 In distribution
3603-0-0104 Tibial Prep Guide, Chisel, Sharp, Press, Dual Ended, Sz 4 In distribution
3000-1-1606 FEMORAL SIZER, CTR HANDLE, SIZE 6 In distribution
3060-0-3414 Trial, Tibial Insert, Size 3/4, 14mm In distribution
3000-0-0070 In distribution
3260-0-0001 In distribution
3000-1-1704 Femoral Drill Guide, Anterior paddle; Med/Lat, Size 4 In distribution
3260-0-0003 In distribution
3060-0-5609 Trial, Tibial Insert, Size 5/6, 9mm In distribution
3000-0-1704 In distribution
3602-0-0004 In distribution
3000-1-0070 Tibial Cut Block, Noncaptured, RL/LM, Extra Patella CLR, ASSY In distribution
3060-0-7814 Trial, Tibial Insert, Size 7/8, 14mm In distribution
3000-1-1513 FEMORAL CUT BLOCK, NON-CAPTURED, OFFSET CUTOUT, SIZE 3 In distribution
3260-1-0002 TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 2 In distribution
3602-0-0008 In distribution
3060-0-5611 Trial, Tibial Insert, Size 5/6, 11mm In distribution
3000-1-1707 Femoral Drill Guide, Anterior paddle; Med/Lat, Size 7 In distribution
3603-0-0108 Tibial Prep Guide, Chisel, Sharp, Press, Dual Ended, Sz 8 In distribution
3000-1-1601 FEMORAL SIZER, CTR HANDLE, SIZE 1 In distribution
3260-0-0007 In distribution
3603-0-0103 Tibial Prep Guide, Chisel, Sharp, Press, Dual Ended, Sz 3 In distribution
3060-0-1211 Trial, Tibial Insert, Size 1/2, 11mm In distribution
3601-0-0008 In distribution
3600-0-0005 In distribution
3000-1-1603 FEMORAL SIZER, CTR HANDLE, SIZE 3 In distribution
3000-1-1605 FEMORAL SIZER, CTR HANDLE, SIZE 5 In distribution
3000-0-1708 In distribution
3060-0-7808 Trial, Tibial Insert, Size 7/8, 8mm In distribution
3000-1-1511 FEMORAL CUT BLOCK, NON-CAPTURED, OFFSET CUTOUT, SIZE 1 In distribution
3060-0-1210 Trial, Tibial Insert, Size 1/2, 10mm In distribution
3260-1-0001 TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 1 In distribution
3060-0-7811 Trial, Tibial Insert, Size 7/8, 11mm In distribution
3000-0-1706 In distribution
3060-0-3408 Trial, Tibial Insert, Size 3/4, 8mm In distribution
3060-0-5613 Trial, Tibial Insert, Size 5/6, 13mm In distribution
3601-0-0006 In distribution
3600-0-0001 In distribution
3000-0-1602 In distribution
3600-0-0110 TIBIAL SIZER, FEELER GAGE In distribution
3060-0-0009 Trial, Tibial Insert, Size 0, 9mm In distribution
3000-0-1702 In distribution
3000-1-1703 Femoral Drill Guide, Anterior paddle; Med/Lat, Size 3 In distribution
3000-1-1516 FEMORAL CUT BLOCK, NON-CAPTURED, OFFSET CUTOUT, SIZE 6 In distribution
3601-0-0004 In distribution
3000-1-1518 FEMORAL CUT BLOCK, NON-CAPTURED, OFFSET CUTOUT, SIZE 8 In distribution
3602-0-0005 In distribution
3060-0-1214 Trial, Tibial Insert, Size 1/2, 14mm In distribution
3603-0-0101 Tibial Prep Guide, Chisel, Sharp, Press, Dual Ended, Sz 1 In distribution
3000-0-1606 In distribution
3602-0-0000 In distribution
3060-0-0012 Trial, Tibial Insert, Size 0, 12mm In distribution
3000-1-0052 Femoral Stop Drill, Posterior, Long, 5.2mm In distribution
3600-0-0004 In distribution
3260-0-0002 In distribution
3601-0-0007 In distribution
3602-0-0003 In distribution
3000-1-1515 FEMORAL CUT BLOCK, NON-CAPTURED, OFFSET CUTOUT, SIZE 5 In distribution
3260-1-0004 TRIAL, FEMORAL, OFFSET CUTOUT, SIZE 4 In distribution
3060-0-7809 Trial, Tibial Insert, Size 7/8, 9mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Attune Depuy (Ireland) 1,385
Template Exactech, Inc. 1,277
4WEB Medical 4WEB Inc. 991
Evolution® Microport Orthopedics Inc. 966
Template Zimmer, Inc. 792
Advance® Microport Orthopedics Inc. 644
Apex Knee System Omni Life Science, Inc. 635
Profemur® Microport Orthopedics Inc. 591
Link Instruments – Trial implants and size gauges Waldemar Link GmbH & Co. KG 549
Template Synthes Gmbh 516
Optetrak Logic Exactech, Inc. 512
Template Depuy Spine, Inc. 451

Showing 12 of 2,940. All products under Template

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer