Optetrak Logic

TRIAL, CR TIBIAL INSERT, LOGIC®, SIZE 1.5, 13mm, SLOPE ++

Registry build 21.09.26
21manufacturers in China registered for this device type
512catalogue 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 Optetrak Logic
Listed by Exactech, Inc., United States
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
Premarket notification Exempt
Record published 2022-08-25
Record revised 2024-02-28 (version 3)

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
Sizes Height 3 to 29 mm; outer diameter 10 to 24 mm; length 25 to 160 mm
Distribution end date 2024-06-13

Catalogue Numbers

Catalogue numbers for Optetrak Logic
Catalogue number Size Status
02-013-47-2009 Height 9 mm In distribution
02-013-60-1680 Outer Diameter 16 mm In distribution
02-013-47-2011 Height 11 mm In distribution
02-011-06-0740 SIZE 4 In distribution
02-013-44-5009 SIZE 5 In distribution
02-013-48-2011 SIZE 2 In distribution
02-011-06-0910 SIZE 1 In distribution
02-013-44-0009 Height 9 mm In distribution
02-013-65-2129 SIZE 2 In distribution
02-013-35-3513 SIZE 3.5 In distribution
02-013-44-0013 Height 13 mm In distribution
02-013-58-3509 SIZE 3.5 In distribution
02-013-35-2511 Height 11 mm In distribution
02-013-50-3011 Height 5 mm In distribution
02-013-48-2009 Height 9 mm In distribution
02-013-65-3129 Height 29 mm In distribution
02-013-49-0011 SIZE 0 In distribution
02-011-06-0640 LEFT In distribution
02-013-35-0009 Height 9 mm In distribution
02-013-44-4009 Height 9 mm In distribution
02-013-48-5013 SIZE 5 In distribution
02-013-49-2009 SIZE 2 In distribution
02-013-50-1511 Height 5 mm In distribution
02-011-06-0150 SIZE 5 In distribution
02-013-44-3509 Height 9 mm In distribution
02-013-65-5117 Height 17 mm In distribution
02-013-51-0009 SIZE 0 In distribution
02-013-44-6011 Height 11 mm In distribution
02-013-47-6015 Height 15 mm In distribution
02-013-35-1515 SIZE 1.5 In distribution
02-013-49-1011 Height 11 mm In distribution
02-013-60-1212 Outer Diameter 12 mm In distribution
02-013-65-5125 Height 25 mm In distribution
02-013-48-1009 Height 9 mm In distribution
02-013-60-1612 Outer Diameter 16 mm In distribution
02-013-44-1515 Height 15 mm In distribution
02-013-57-3515 Height 15 mm In distribution
02-013-65-4125 SIZE 4 In distribution
02-013-49-3011 SIZE 3 In distribution
02-013-51-2013 Height 13 mm In distribution
02-013-60-1412 Length 120 mm In distribution
02-013-51-1013 SIZE 1 In distribution
02-013-57-3513 Height 13 mm In distribution
02-013-51-3011 SIZE 3 In distribution
02-013-50-2014 Height 10 mm In distribution
02-013-44-2013 Height 13 mm In distribution
02-019-95-0160 SIZE 6 In distribution
02-013-65-2125 Height 25 mm In distribution
02-011-01-0325 RIGHT In distribution
02-013-35-3009 Height 9 mm In distribution
02-013-45-9310 SIZE 0 In distribution
02-011-07-5510 Height 10 mm In distribution
02-019-95-0140 SIZE 4 In distribution
02-019-95-0120 SIZE 2 In distribution
02-013-50-5012 SIZE 5 In distribution
02-013-47-5015 Height 15 mm In distribution
02-013-49-5009 SIZE 5 In distribution
02-011-06-0940 SIZE 4 In distribution
02-013-51-3511 SIZE 3.5 In distribution
02-013-48-1513 In distribution
02-013-59-3509 Height 9 mm In distribution
02-013-51-1011 SIZE 1 In distribution
02-011-03-0210 LEFT In distribution
02-011-01-0235 LEFT In distribution
02-011-01-0315 RIGHT In distribution
02-011-03-0360 SIZE 6 In distribution
02-011-06-0750 RIGHT In distribution
02-013-65-4115 SIZE 4 In distribution
02-013-65-4121 Height 21 mm In distribution
02-013-45-9460 SIZE 6 In distribution
02-013-35-1013 Height 13 mm In distribution
02-013-50-2512 SIZE 2.5 In distribution
02-011-06-0630 SIZE 3 In distribution
02-013-35-3511 Height 11 mm In distribution
02-011-03-0310 SIZE 1 In distribution
02-013-47-3011 Height 11 mm In distribution
02-013-47-0011 SIZE 0, NEUTRAL In distribution
02-013-49-6013 SIZE 6 In distribution
02-013-52-1508 Height 8 mm In distribution
02-013-47-1509 In distribution
02-013-58-1509 Height 9 mm In distribution
02-013-50-1012 SIZE 1 In distribution
02-013-49-4009 Height 11 mm In distribution
02-011-03-0215 SIZE 1.5 In distribution
02-011-07-4015 Height 10 mm In distribution
02-013-48-1013 Height 13 mm In distribution
02-013-35-2000 SIZE 2 In distribution
02-011-01-0250 LEFT In distribution
02-013-35-2015 Height 15 mm In distribution
02-013-47-0015 SIZE 0, NEUTRAL In distribution
02-011-03-0250 LEFT In distribution
02-013-48-0011 Height 11 mm In distribution
02-011-06-0120 SIZE 2 In distribution
02-011-06-0402 Height 10 mm In distribution
02-013-65-3109 Height 9 mm In distribution
02-013-45-9420 SIZE 2 In distribution
02-011-01-0260 SIZE 6 In distribution
02-019-95-0100 SIZE 0 In distribution
02-011-06-0950 RIGHT In distribution
02-013-57-2511 SIZE 2.5 In distribution
02-013-45-9410 SIZE 1 In distribution
02-013-65-1117 Height 17 mm In distribution
02-013-49-3009 SIZE 3 In distribution
02-011-01-0340 RIGHT In distribution
02-013-44-0015 Height 15 mm In distribution
02-013-51-1513 SIZE 1.5 In distribution
02-013-51-1511 Height 11 mm In distribution
02-013-58-1511 SIZE 1.5 In distribution
02-013-49-5011 Height 11 mm In distribution
02-013-49-2011 Height 11 mm In distribution
02-011-01-0200 SIZE 0 In distribution
02-013-48-1011 Height 11 mm In distribution
02-013-44-1011 SIZE 1 In distribution
02-013-45-9340 SIZE 4 In distribution
02-013-58-2513 Height 13 mm In distribution
02-013-60-1316 Outer Diameter 13 mm In distribution
02-011-03-0350 RIGHT In distribution
02-011-06-0492 SIZE 3-5 In distribution
02-013-35-6009 Height 9 mm In distribution
02-013-50-4014 Height 10 mm In distribution
02-013-35-1513 Height 13 mm In distribution
02-011-06-0140 SIZE 4 In distribution
02-013-60-1480 Outer Diameter 14 mm In distribution
02-013-47-0009 SIZE 0, NEUTRAL In distribution
02-013-35-5015 SIZE 5 In distribution
02-013-65-3000 SIZE 3 In distribution
02-013-50-0512 Height 5 mm In distribution
02-013-51-1515 SIZE 1.5 In distribution
02-013-58-2509 SIZE 2.5 In distribution
02-013-47-6011 SIZE 6 In distribution
02-011-06-0403 SIZE 1-2 In distribution
02-013-44-2011 SIZE 2 In distribution
02-013-48-6009 SIZE 6 In distribution
02-013-44-2015 Height 15 mm In distribution
02-013-65-5129 Height 29 mm In distribution
02-011-03-0235 SIZE 3.5 In distribution
02-011-03-0240 SIZE 4 In distribution
02-013-65-4109 SIZE 4 In distribution
02-013-35-0013 Height 13 mm In distribution
02-013-51-2015 Height 15 mm In distribution
02-011-06-0650 LEFT In distribution
02-013-65-4129 SIZE 4 In distribution
02-013-50-2511 Height 5 mm In distribution
02-011-07-3510 SIZE 3 In distribution
02-013-50-3014 SIZE 3 In distribution
02-011-01-0300 SIZE 0 In distribution
02-013-50-1514 SIZE 1.5 In distribution
02-013-51-1009 Height 9 mm In distribution
02-013-60-1225 Length 25 mm In distribution
02-013-65-2115 SIZE 2 In distribution
02-013-44-5011 SIZE 5 In distribution
02-013-35-4009 Height 9 mm In distribution
02-013-45-9320 SIZE2 In distribution
02-013-61-4206 Outer Diameter 20 mm In distribution
02-011-01-0210 SIZE 1 In distribution
02-013-50-1513 SIZE 1.5 In distribution
02-013-35-3509 Height 9 mm In distribution
02-013-65-1111 Height 11 mm In distribution
02-013-44-1511 SIZE 1.5 In distribution
02-011-06-0920 SIZE 2 In distribution
02-011-01-0220 SIZE 2 In distribution
02-019-95-0150 SIZE 5 In distribution
02-013-61-4146 Outer Diameter 14 mm In distribution
02-013-51-3009 SIZE 3 In distribution
02-013-65-3113 Height 13 mm In distribution
02-013-65-3111 Height 11 mm In distribution
02-013-51-0013 Height 13 mm In distribution
02-013-44-6015 SIZE 6 In distribution
02-013-50-4511 SIZE 4.5 In distribution
02-013-51-2515 SIZE 2.5 In distribution
02-013-59-1513 SIZE 1.5 In distribution
02-013-65-2111 Height 11 mm In distribution
02-013-60-1516 Length 160 mm In distribution
02-011-01-0230 LEFT In distribution
02-013-48-3009 Height 9 mm In distribution
02-013-47-1013 Height 13 mm In distribution
02-013-57-1509 Height 9 mm In distribution
02-013-45-9350 SIZE 5 In distribution
02-013-60-1240 Length 40 mm In distribution
02-013-35-5013 SIZE 5 In distribution
02-013-44-2513 Height 13 mm In distribution
02-013-51-4015 SIZE 4 In distribution
02-011-03-0335 RIGHT In distribution
02-013-51-0011 Height 11 mm In distribution
02-013-61-4166 Outer Diameter 16 mm In distribution
02-013-50-2012 Height 5 mm In distribution
02-013-50-0511 Height 5 mm In distribution
02-011-03-0325 SIZE 2.5 In distribution
02-013-51-2509 Height 9 mm In distribution
02-013-48-0013 Height 13 mm In distribution
02-019-95-0135 SIZE 3 In distribution
02-013-44-2000 SIZE 2 In distribution
02-013-44-3015 SIZE 3 In distribution
02-011-06-0720 SIZE 2 In distribution
02-013-50-1013 SIZE 1 In distribution
02-013-51-4011 SIZE 4 In distribution
02-013-49-1013 Height 13 mm In distribution
02-013-51-6013 Height 13 mm In distribution
02-013-59-3513 SIZE 3.5 In distribution
02-013-50-5011 SIZE 5 In distribution
02-013-60-1580 Length 80 mm In distribution
02-013-60-1025 Length 25 mm In distribution
02-013-44-6009 Height 9 mm In distribution
02-013-44-1015 Height 15 mm In distribution
02-013-50-4013 Height 10 mm In distribution
02-013-35-4013 Height 13 mm In distribution
02-011-06-0493 SIZE 3-5 In distribution
02-013-48-6011 Height 11 mm In distribution
02-013-61-4186 Outer Diameter 18 mm In distribution
02-013-50-6013 Height 10 mm In distribution
02-013-48-3011 Height 11 mm In distribution
02-013-48-4013 Height 13 mm In distribution
02-013-35-1511 Height 11 mm In distribution
02-019-95-0115 SIZE 1.5 In distribution
02-013-50-5013 Height 10 mm In distribution
02-013-35-5011 SIZE 5 In distribution
02-013-51-6009 SIZE 5 In distribution
02-013-65-3121 SIZE 3 In distribution
02-011-07-3015 SIZE 3 In distribution
02-013-50-3012 SIZE 3 In distribution
02-013-49-3013 SIZE 3 In distribution
02-011-07-4510 Height 10 mm In distribution
02-013-48-4011 Height 11 mm In distribution
02-013-48-5011 Height 11 mm In distribution
02-013-51-4009 Height 9 mm In distribution
02-011-07-2510 Height 15 mm In distribution
02-011-01-0215 SIZE 1.5 In distribution
02-013-65-4117 Height 17 mm In distribution
02-013-45-9450 SIZE 5 In distribution
02-013-58-3511 SIZE 3.5 In distribution
02-013-51-3013 SIZE 3 In distribution
02-013-65-1000 SIZE 1 In distribution
02-013-65-2000 SIZE 2 In distribution
02-013-47-6009 SIZE 6 In distribution
02-013-49-5013 SIZE 5 In distribution
02-013-51-1015 Height 15 mm In distribution
02-011-06-0401 Height 5 mm In distribution
02-011-07-2015 Height 15 mm In distribution
02-013-51-3515 SIZE 3.5 In distribution
02-013-51-2511 SIZE 2.5 In distribution
02-013-65-1125 SIZE 1 In distribution
02-013-44-5000 SIZE 5 In distribution
02-013-65-5115 Height 15 mm In distribution
02-013-38-3009 Height 9 mm In distribution
02-013-44-3013 SIZE 3 In distribution
02-013-50-3511 Height 10 mm In distribution
02-013-48-3013 SIZE 3 In distribution
02-013-50-4513 SIZE 4.5 In distribution
02-011-03-0230 LEFT In distribution
02-013-50-2513 Height 10 mm In distribution

Showing 250 of 300 catalogue numbers.

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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