Lospa TKR System

LOSPA Tibial Insert Trial CR #03 T08

Registry build 21.09.26
21manufacturers in China registered for this device type
198catalogue 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 Lospa TKR System
Listed by Corentec Co., Ltd., South Korea
FDA product code HWT
Device type Template
Device class Class 1
Regulation 21 CFR 888.4800
Establishment Manufacturer, Exporter
510(k) K212034
Record published 2021-12-31
Record revised 2022-03-22 (version 2)

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, manufacturing date

Catalogue Numbers

Catalogue numbers for Lospa TKR System
Catalogue number Size Status
KA.SPS.1208 In distribution
KA.SPS.1614 In distribution
KA.SCR.1420 In distribution
KA.SPS.0320 In distribution
KA.SPS.1222 In distribution
KA.SPS.1310 In distribution
KA.SPS.0310 In distribution
KA.SPS.1608 In distribution
KA.SPS.0622 In distribution
KA.SPS.0708 In distribution
KA.SCR.0924 In distribution
KA.SCR.1222 In distribution
KA.SPS.1412 In distribution
KA.SPS.0616 In distribution
KA.SCR.1212 In distribution
KA.SCR.0714 In distribution
KA.SCR.0424 In distribution
KA.SCR.1610 In distribution
KA.SPS.1322 In distribution
KA.SCR.1422 In distribution
KA.SCR.1314 In distribution
KA.SPS.0608 In distribution
KA.SPS.1622 In distribution
KA.SCR.0624 In distribution
KA.SCR.0618 In distribution
KA.SPS.1312 In distribution
KA.SCR.0616 In distribution
KA.SPS.0314 In distribution
KA.SPS.0408 In distribution
KA.SCR.0710 In distribution
KA.SPS.0318 In distribution
KA.SPS.0618 In distribution
KA.SCR.0508 In distribution
KA.SPS.1416 In distribution
KA.SCR.0718 In distribution
KA.SCR.0610 In distribution
KA.SCR.1210 In distribution
KA.SCR.1112 In distribution
KA.SPS.0414 In distribution
KA.SCR.1424 In distribution
KA.SPS.1116 In distribution
KA.SCR.0520 In distribution
KA.SCR.1316 In distribution
KA.SPS.0612 In distribution
KA.SCR.0524 In distribution
KA.SPS.0620 In distribution
KA.SPS.0716 In distribution
KA.SPS.1616 In distribution
KA.SPS.0524 In distribution
KA.SCR.0414 In distribution
KA.SCR.0716 In distribution
KA.SCR.1114 In distribution
KA.SPS.0410 In distribution
KA.SPS.1618 In distribution
KA.SCR.0316 In distribution
KA.SPS.1320 In distribution
KA.SPS.0908 In distribution
KA.SPS.1220 In distribution
KA.SCR.1616 In distribution
KA.SCR.0916 In distribution
KA.SCR.0722 In distribution
KA.SPS.0424 In distribution
KA.SPS.0920 In distribution
KA.SCR.0514 In distribution
KA.SCR.0412 In distribution
KA.SCR.0416 In distribution
KA.SPS.0922 In distribution
KA.SCR.0910 In distribution
KA.SPS.1218 In distribution
KA.SCR.1410 In distribution
KA.SPS.1418 In distribution
KA.SCR.1622 In distribution
KA.SCR.0318 In distribution
KA.SPS.0522 In distribution
KA.SCR.0522 In distribution
KA.SPS.0510 In distribution
KA.SCR.0620 In distribution
KA.SPS.1610 In distribution
KA.SCR.1124 In distribution
KA.SPS.1210 In distribution
KA.SCR.1412 In distribution
KA.SCR.1208 In distribution
KA.SPS.1124 In distribution
KA.SCR.1608 In distribution
KA.SCR.0724 In distribution
KA.SCR.0612 In distribution
KA.SPS.0416 In distribution
KA.SCR.0516 In distribution
KA.SPS.0420 In distribution
KA.SCR.1408 In distribution
KA.SPS.0610 In distribution
KA.SPS.0322 In distribution
KA.SPS.1216 In distribution
KA.SPS.1212 In distribution
KA.SCR.0922 In distribution
KA.SCR.0408 In distribution
KA.SPS.1114 In distribution
KA.SPS.1612 In distribution
KA.SCR.1214 In distribution
KA.SCR.1614 In distribution
KA.SCR.0708 In distribution
KA.SCR.1224 In distribution
KA.SCR.0614 In distribution
KA.SCR.1418 In distribution
KA.SPS.1120 In distribution
KA.SCR.0914 In distribution
KA.SPS.0916 In distribution
KA.SCR.0912 In distribution
KA.SCR.1414 In distribution
KA.SCR.1120 In distribution
KA.SCR.1108 In distribution
KA.SCR.0308 In distribution
KA.SCR.0918 In distribution
KA.SPS.0718 In distribution
KA.SPS.0520 In distribution
KA.SCR.1308 In distribution
KA.SPS.0724 In distribution
KA.SPS.1410 In distribution
KA.SPS.0312 In distribution
KA.SCR.0418 In distribution
KA.SPS.0308 In distribution
KA.SCR.1220 In distribution
KA.SPS.0624 In distribution
KA.SPS.0518 In distribution
KA.SCR.0420 In distribution
KA.SPS.1424 In distribution
KA.SPS.0722 In distribution
KA.SPS.1420 In distribution
KA.SPS.0516 In distribution
KA.SCR.0410 In distribution
KA.SCR.0908 In distribution
KA.SCR.1310 In distribution
KA.SCR.1312 In distribution
KA.SCR.0920 In distribution
KA.SPS.0914 In distribution
KA.SCR.1318 In distribution
KA.SCR.0720 In distribution
KA.SPS.1224 In distribution
KA.SPS.0316 In distribution
KA.SCR.1216 In distribution
KA.SPS.0720 In distribution
KA.SCR.0622 In distribution
KA.SPS.1620 In distribution
KA.SPS.1316 In distribution
KA.SCR.1620 In distribution
KA.SCR.0320 In distribution
KA.SCR.0322 In distribution
KA.SCR.1624 In distribution
KA.SPS.0714 In distribution
KA.SPS.0508 In distribution
KA.SPS.1414 In distribution
KA.SPS.0324 In distribution
KA.SPS.0422 In distribution
KA.SPS.0712 In distribution
KA.SPS.0918 In distribution
KA.SCR.0512 In distribution
KA.SCR.0324 In distribution
KA.SCR.1118 In distribution
KA.SCR.0608 In distribution
KA.SCR.1618 In distribution
KA.SPS.0710 In distribution
KA.SPS.1422 In distribution
KA.SCR.1320 In distribution
KA.SPS.1308 In distribution
KA.SPS.1110 In distribution
KA.SPS.1318 In distribution
KA.SCR.1218 In distribution
KA.SCR.0312 In distribution
KA.SCR.1612 In distribution
KA.SPS.1108 In distribution
KA.SCR.1116 In distribution
KA.SPS.0912 In distribution
KA.SPS.0614 In distribution
KA.SPS.1408 In distribution
KA.SPS.0412 In distribution
KA.SPS.1122 In distribution
KA.SCR.0314 In distribution
KA.SCR.0510 In distribution
KA.SCR.0422 In distribution
KA.SCR.0712 In distribution
KA.SCR.1122 In distribution
KA.SPS.0910 In distribution
KA.SCR.0310 In distribution
KA.SCR.0518 In distribution
KA.SCR.1110 In distribution
KA.SPS.0924 In distribution
KA.SPS.0418 In distribution
KA.SPS.1214 In distribution
KA.SPS.0512 In distribution
KA.SCR.1324 In distribution
KA.SPS.1118 In distribution
KA.SPS.1314 In distribution
KA.SPS.1324 In distribution
KA.SCR.1416 In distribution
KA.SPS.1112 In distribution
KA.SPS.1624 In distribution
KA.SPS.0514 In distribution
KA.SCR.1322 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