Peak Fx™lag Assembly

54 catalogue numbers from 8142-33-320, listed by Biomet Orthopedics, United States, under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component. 17 manufacturers in China are registered for this product code.

Registry build 21.09.26
17manufacturers in China registered for this device type
54catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KTT
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
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
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Suzhou Ahno Medical Devices Co., Ltd. Suzhou Jiangsu Contract manufacturer 17
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Hangzhou Sino-MIM Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 6
Suzhou AND Science & Technology Development Corp. Zhangjiagang Jiangsu Contract manufacturer 5

Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Record

Regulatory record for Peak Fx™lag Assembly
Listed by Biomet Orthopedics, United States
FDA product code KTT
Device type Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class Class 2
Regulation 21 CFR 888.3030
510(k) K063509
Record published 2015-10-24
Record revised 2025-05-30 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Distribution end date 2021-08-26

Catalogue Numbers

Catalogue numbers for Peak Fx™lag Assembly
Catalogue number Size Status
8142-33-320 120MM X 135 Withdrawn
8142-32-100 100MM X 130 Withdrawn
8142-33-470 70MM X 125 Withdrawn
8142-32-390 90MM X 135 Withdrawn
8142-33-480 80MM X 125 Withdrawn
8142-33-100 100MM X 130 Withdrawn
8142-32-490 90MM X 125 Withdrawn
8142-32-380 80MM X 135 Withdrawn
8142-32-480 80MM X 125 Withdrawn
8142-32-330 130MM X 135 Withdrawn
8142-33-490 90MM X 125 Withdrawn
8142-32-230 130MM X 140 Withdrawn
8142-32-130 130MM X 130 Withdrawn
8142-33-200 100MM X 140 Withdrawn
8142-32-220 120MM X 140 Withdrawn
8142-32-120 120MM X 130 Withdrawn
8142-32-370 70MM X 135 Withdrawn
8142-33-130 130MM X 130 Withdrawn
8142-33-210 110MM X 140 Withdrawn
8142-33-370 70MM X 135 Withdrawn
8142-32-430 130MM X 125 Withdrawn
8142-33-410 110MM X 125 Withdrawn
8142-33-400 100MM X 125 Withdrawn
8142-33-090 90MM X 130 Withdrawn
8142-32-200 100MM X 140 Withdrawn
8142-33-420 120MM X 125 Withdrawn
8142-32-310 110MM X 135 Withdrawn
8142-32-400 100MM X 125 Withdrawn
8142-32-290 90MM X 140 Withdrawn
8142-33-220 120MM X 140 Withdrawn
8142-32-280 80MM X 140 Withdrawn
8142-33-310 110MM X 135 Withdrawn
8142-33-300 100MM X 135 Withdrawn
8142-32-210 110MM X 140 Withdrawn
8142-33-330 130MM X 135 Withdrawn
8142-33-380 80MM X 135 Withdrawn
8142-32-270 70MM X 140 Withdrawn
8142-32-470 70MM X 125 Withdrawn
8142-32-410 110MM X 125 Withdrawn
8142-33-110 110MM X 130 Withdrawn
8142-32-300 100MM X 135 Withdrawn
8142-33-290 90MM X 140 Withdrawn
8142-32-110 110MM X 130 Withdrawn
8142-33-070 70MM X 130 Withdrawn
8142-32-420 120MM X 125 Withdrawn
8142-33-430 130MM X 125 Withdrawn
8142-33-280 80MM X 140 Withdrawn
8142-33-080 80MM X 130 Withdrawn
8142-32-080 80MM X 130 Withdrawn
8142-32-090 90MM X 130 Withdrawn
8142-33-120 120MM X 130 Withdrawn
8142-33-270 70MM X 140 Withdrawn
8142-32-320 120MM X 135 Withdrawn
8142-32-070 70MM X 130 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Smart Correction Wishbone Medical Inc. 1,534
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Synthes Gmbh 880
LCP Synthes Gmbh 355
Orthex External Fixation System Orthopediatrics, Corp 353
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Sterilmed, Inc. 325
CHS Smith & Nephew, Inc. 321
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Stryker Sustainability Solutions 277
Hoffmann Stryker GmbH 239
Orthex Orthopediatrics, Corp 231
Orthex Vilex IN Tennessee, Inc. 221
Omega Stryker GmbH 212
eZ-Fix Orthopediatrics, Corp 207

Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

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