Acumed

Forefoot/Midfoot Plating Module PL-FAM12

Registry build 21.09.26
105manufacturers in China registered for this device type
566catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FSM
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Gcmedica Enterprise Ltd.(Wuxi) Wuxi Jiangsu Contract manufacturer 55
Paragon Medical Device (Changzhou) Co., Ltd. Changzhou Jiangsu Contract manufacturer 53
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Danyang Jiangsu Contract manufacturer 37
BH Medical Products Co., Ltd. Changzhou Jiangsu Contract manufacturer 37
Guangzhou Aquila Precise Tools Limited Guangzhou Guangdong Contract manufacturer 28
Mobility Source Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 26
Guangdong Shunde LQX Health Technology Inc. Foshan Guangdong Contract manufacturer 24

Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument

Record

Regulatory record for Acumed
Listed by Acumed LLC, United States
FDA product code FSM
Device type Tray, Surgical, Instrument
Device class Class 1
Regulation 21 CFR 878.4800
Establishment Specification developer, Repacker / relabeller, Manufacturer
510(k) K141383
Record published 2015-10-24
Record revised 2022-09-16 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date
Distribution end date 2021-12-02

Catalogue Numbers

Catalogue numbers for Acumed
Catalogue number Size Status
80-0002 In distribution
PL-WF04 In distribution
80-0587 In distribution
80-1820 In distribution
80-0842 In distribution
80-4384 In distribution
80-1988 In distribution
80-1914 In distribution
80-0436 In distribution
80-1819 In distribution
AP-0500 In distribution
80-0140 In distribution
80-0314 In distribution
80-1823 In distribution
AT2-C003 In distribution
80-1932 In distribution
PL-2250 In distribution
AT2-004 In distribution
80-0881 In distribution
BG-8070 In distribution
DR-011 In distribution
81-1988 In distribution
80-2520 In distribution
80-0289 In distribution
80-1158 In distribution
80-0476 In distribution
80-0475 In distribution
80-0290 In distribution
80-2383 In distribution
PL-FAM11 In distribution
80-0396 In distribution
80-1921 In distribution
80-1410 In distribution
80-1934 In distribution
PL-FAM20 In distribution
80-2627 In distribution
80-1519 In distribution
PL-FAM12 In distribution
80-0125 In distribution
PL-2260 In distribution
80-4182 In distribution
80-1337 In distribution
80-1515 In distribution
80-4392 In distribution
80-1917 In distribution
80-3683 In distribution
80-1814 In distribution
10100004 In distribution
PL-WF06 In distribution
PL-2255 In distribution
80-3945 In distribution
PL-WF01 In distribution
80-0137 In distribution
80-0126 In distribution
80-1918 In distribution
80-4201 In distribution
80-2247 In distribution
80-0045 In distribution
81-1327 In distribution
80-0121 In distribution
FA-9040 In distribution
80-1997 In distribution
80-0819 In distribution
81-1987 In distribution
80-0751 In distribution
PL-FAM40 In distribution
80-0120 In distribution
MS-9000 In distribution
80-0301 In distribution
80-2341 In distribution
80-0864 In distribution
PL-LEL03 In distribution
80-0313 In distribution
80-0841 In distribution
80-2536 In distribution
PL-2057 In distribution
80-0395 In distribution
80-4176 In distribution
DR-014 In distribution
80-0393 In distribution
80-2531 In distribution
80-0018 In distribution
AT2-M600 In distribution
81-1338 In distribution
80-0073 In distribution
80-1813 In distribution
80-1067 In distribution
80-2249 In distribution
80-0076 In distribution
80-0458 In distribution
80-0579 In distribution
80-0812 In distribution
80-0839 In distribution
80-0183 In distribution
80-2091 In distribution
AT2-S002 In distribution
AT2-077 In distribution
80-4394 In distribution
LCL-03 In distribution
AT-7019 In distribution
80-0292 In distribution
80-1514 In distribution
81-1337 In distribution
80-2522 In distribution
80-1927 In distribution
80-1704 In distribution
80-1935 In distribution
AT2-M002 In distribution
80-0172 In distribution
80-1684 In distribution
PL-WF08 In distribution
80-0346 In distribution
80-1500 In distribution
80-0364 In distribution
PL-WFL3 In distribution
80-0130 In distribution
80-3767 In distribution
80-1517 In distribution
80-1526 In distribution
80-1685 In distribution
80-1531 In distribution
80-0116 In distribution
80-1683 In distribution
80-0880 In distribution
80-0264 In distribution
80-4385 In distribution
80-1915 In distribution
TR-0001 In distribution
80-0377 In distribution
80-0679 In distribution
80-4198 In distribution
80-0425 In distribution
AT2-007 In distribution
10100003 In distribution
80-0343 In distribution
80-2343 In distribution
80-0287 In distribution
80-0122 In distribution
PL-PH04 In distribution
80-0133 In distribution
PL-WF07 In distribution
80-4186 In distribution
80-0857 In distribution
MTP-0500 In distribution
80-2000 In distribution
80-1160 In distribution
80-1920 In distribution
80-1928 In distribution
80-0277 In distribution
80-0513 In distribution
80-3680 In distribution
80-1330 In distribution
80-0132 In distribution
80-4177 In distribution
80-3927 In distribution
80-1010 In distribution
80-0341 In distribution
80-0011 In distribution
80-4181 In distribution
80-2092 In distribution
80-2387 In distribution
LCL-02 In distribution
80-4173 In distribution
80-0840 In distribution
80-3682 In distribution
80-0279 In distribution
80-0035 In distribution
80-0036 In distribution
80-0352 In distribution
80-0638 In distribution
80-0115 In distribution
80-0312 In distribution
PL-WF03 In distribution
80-1824 In distribution
80-0430 In distribution
80-4111 In distribution
80-1701 In distribution
80-3768 In distribution
80-2250 In distribution
ATF-061 In distribution
SM-5061 In distribution
80-0586 In distribution
80-2529 In distribution
80-0428 In distribution
80-3949 In distribution
80-2384 In distribution
80-0518 In distribution
80-0746 In distribution
80-0810 In distribution
AT2-S500 In distribution
80-2385 In distribution
80-0809 In distribution
80-1325 In distribution
PL-PH01 In distribution
AT2-S003 In distribution
80-0109 In distribution
80-0077 In distribution
PL-FAM42 In distribution
80-0107 In distribution
80-1815 In distribution
80-1408 In distribution
LCL-06 In distribution
80-4175 In distribution
80-0883 In distribution
80-0129 In distribution
80-1516 In distribution
PL-PH02 In distribution
80-0127 In distribution
80-1009 In distribution
PL-PH03 In distribution
81-1223 In distribution
80-0342 In distribution
LCL-01 In distribution
80-1223 In distribution
AM-5040 In distribution
TR-0005 In distribution
PL-2275 In distribution
80-0525 In distribution
AT-7017 In distribution
80-4185 In distribution
80-0486 In distribution
80-0675 In distribution
AT2-002 In distribution
80-1931 In distribution
80-3926 In distribution
80-0641 In distribution
80-0885 In distribution
80-0826 In distribution
80-2628 In distribution
80-2090 In distribution
80-0391 In distribution
80-0818 In distribution
PL-FAM41 In distribution
80-2720 In distribution
PL-FAM13 In distribution
80-0376 In distribution
80-2530 In distribution
80-0134 In distribution
80-2519 In distribution
80-1527 In distribution
80-0288 In distribution
FA-9030 In distribution
80-0676 In distribution
80-4386 In distribution
80-0752 In distribution
80-1332 In distribution
MS-1001 In distribution
80-0046 In distribution
80-0108 In distribution
80-3480 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
IMS HU-Friedy MFG Co., LLC 2,710
Tray, Surgical, Instrument Synthes Gmbh 1,052
Tray, Surgical, Instrument Medtronic Sofamor Danek, Inc. 1,012
Hu-Friedy MFG Co., LLC. HU-Friedy MFG Co., LLC 666
Aptus Medartis Inc. 588
Aesculap Aesculap AG 532
Sklar Sklar Corporation 465
Hu-Friedy HU-Friedy MFG Co., LLC 438
Nordent Manufacturing Inc Nordent Manufacturing Inc 429
Level ONE KLS-Martin L.P. 341
Bahadir USA Bahadir USA LLC 300
Devon Cardinal Health 254

Showing 12 of 3,212. All products under Tray, Surgical, Instrument

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