NON-BR2000 Large Bone Blades

BR2108-109-000S9

Registry build 21.09.26
25manufacturers in China registered for this device type
90catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (7), Guangdong (7), Shanghai (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GFA
Manufacturer City Province Registered as Device types
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Dongguan Miqiang Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 15
Zhejiang Longyou Landmedical Technology Co., Ltd. Longyou Zhejiang Contract manufacturer 7
Ningbo Advan Electrical Co., Ltd. Cixi Zhejiang Contract manufacturer 5
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
MicroPort Orthopedics Global Supply Center Limited Shanghai Shanghai Contract manufacturer 82
Zhejiang Biomet Medical Products Co., Ltd. Jinhua Zhejiang Contract manufacturer 74
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62

Showing 12 of 25. All 25 manufacturers in China registered for Blade, Saw, General & Plastic Surgery, Surgical

Record

Regulatory record for NON-BR2000 Large Bone Blades
Listed by Peter Brasseler Holdings, LLC
FDA product code GFA
Device type Blade, Saw, General & Plastic Surgery, Surgical
Device class Class 1
Regulation 21 CFR 878.4820
Premarket notification Exempt
Record published 2025-03-13

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for NON-BR2000 Large Bone Blades
Catalogue number Size Status
BR4125-089-075 In distribution
BR2108-158 In distribution
BR4125-147-090 In distribution
BR2108-107-4S1 In distribution
KM-275R In distribution
BR2108-103 In distribution
BR2108-120-6 In distribution
BR2108-107-9 In distribution
BR5072-181 In distribution
BR2108-151 In distribution
BR4118-127-100 In distribution
BR2108-156 In distribution
BR2108-183-1 In distribution
BR2108-105 In distribution
BR11-2220 In distribution
BR4111-127-090 In distribution
BR4125-089-090 In distribution
BR11-2325 In distribution
KM-458 In distribution
BR2108-100 In distribution
BR2108-125 In distribution
BR2108-218 In distribution
KM-461 In distribution
KM71-201 In distribution
KM71-233 In distribution
BR4125-127-100 In distribution
KM71-556 In distribution
BR2108-193 In distribution
BR4111-147-075 In distribution
BR2108-160 In distribution
BR2108-113 In distribution
BR11-2608 In distribution
BR4135-089-064 In distribution
BR2108-118 In distribution
BR2108-131 In distribution
BR2108-115 In distribution
BR4118-135-090 In distribution
BR2108-109-000S9 In distribution
KM71-553 In distribution
KM71-545 In distribution
BR2108-305 In distribution
BR4118-089-075 In distribution
BR2108-382-2 In distribution
BR4118-127-090 In distribution
BR2108-183 In distribution
BR2108-145 In distribution
BR2108-107-1 In distribution
KM-459 In distribution
BR4125-127-090 In distribution
BR2108-102 In distribution
BR2108-140 In distribution
BR2108-111 In distribution
BR2108-195 In distribution
KM519-15 In distribution
BR5072-101 In distribution
BR4125-107-090 In distribution
BR4125-135-090 In distribution
BR2108-176 In distribution
BR2108-185 In distribution
KM71-551 In distribution
BR4118-089-090 In distribution
KM519-21 In distribution
BR2108-152 In distribution
BR2108-150 In distribution
BR4118-137-090 In distribution
BR2108-309 In distribution
KM71-572 In distribution
BR11-2212 In distribution
BR2108-107-4 In distribution
KM-277R In distribution
BR2108-109 In distribution
BR2108-110 In distribution
KM-473 In distribution
BR2108-183-3 In distribution
BR4118-127-075 In distribution
BR511-912S In distribution
BR4118-119-090 In distribution
KM-325R In distribution
BR2108-197 In distribution
BR4125-137-090 In distribution
BR2108-148 In distribution
BR2108-182 In distribution
BR4118-135-105 In distribution
BR2108-177 In distribution
BR11-2222 In distribution
ZB12-0901-19U-R1 In distribution
BR2108-120 In distribution
BR4125-097-090 In distribution
KM71-523 In distribution
BR4111-135-090 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Imedicom SAW Blade Imedicom Co., Ltd. 1,283
Stablecut® Zimmer Orthopaedic Surgical Products 1,154
Medline Medline Industries, Inc. 999
Blade, Saw, General & Plastic Surgery, Surgical Sterilmed, Inc. 994
Komet Surgical Saw Blade Gebr. Brasseler Gmbh & Co. KG 843
Stryker Provision 613
Blade, Saw, General & Plastic Surgery, Surgical Omega Surgical Instruments, Inc. 490
Brasseler USA Peter Brasseler Holdings, LLC 438
Blade, Saw, General & Plastic Surgery, Surgical Stryker GmbH 430
Arthrex® Arthrex, Inc. 213
MicroAire Provision 175
Conmed/Linvatec Provision 175

Showing 12 of 488. All products under Blade, Saw, General & Plastic Surgery, Surgical

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