Blade, Saw, General & Plastic Surgery, Surgical

SAW Blade Oscillating Micro Choice 25.0MM Deep X 9.5MM Wide X.63MM Thickness; 14CM Teeth

Registry build 21.09.26
25manufacturers in China registered for this device type
994catalogue numbers in this listing
1recall

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 Blade, Saw, General & Plastic Surgery, Surgical
Listed by Sterilmed, Inc., United States
FDA product code GFA
Device type Blade, Saw, General & Plastic Surgery, Surgical
Device class Class 1
Regulation 21 CFR 878.4820
Establishment Reprocessor, Specification developer, Manufacturer
Premarket notification Exempt
Record published 2018-06-18
Record revised 2025-07-09 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Distribution end date 2025-07-01

Catalogue Numbers

Catalogue numbers for Blade, Saw, General & Plastic Surgery, Surgical
Catalogue number Size Status
HAL5059-532 Withdrawn
STR2108-197 Withdrawn
KOMKM3-511 Withdrawn
HAL5071-177 Withdrawn
HAL5023-134 Withdrawn
MICZS-038 Withdrawn
STR277-96-300 Withdrawn
KOMKM3-106 Withdrawn
STR2296-3-206 Withdrawn
KOMKMS1313.M61 Withdrawn
KOMKM-695 Withdrawn
HAL5071-305 Withdrawn
DEP5627-55-501 Withdrawn
KOMKM-32 Withdrawn
STR6118-119-90 Withdrawn
KOMKM-625 Withdrawn
STR5400-3-125 Withdrawn
STR2108-356 Withdrawn
STR2296-33-519 Withdrawn
SYN11-3680 Withdrawn
HAL5072-181 Withdrawn
DAN276F1SS Withdrawn
STR2108-109-3 Withdrawn
STR6125-137-110 Withdrawn
MICZS-015 Withdrawn
STR2108-351-2 Withdrawn
KOMKM-7574 Withdrawn
HAL5023-138 Withdrawn
STR6125-97-90 Withdrawn
HAL5023-163 Withdrawn
SYN05.002.202 Withdrawn
LIN5023-138 Withdrawn
MICSR-008 Withdrawn
HAL5071-582 Withdrawn
MICMS-124 Withdrawn
STR2108-382-1S2 Withdrawn
KOMKM-3101 Withdrawn
STR5100-37-11 Withdrawn
BRAK6-25100-50 Withdrawn
MICZR-120 Withdrawn
SMI71440375 Withdrawn
MICSP-411 Withdrawn
STR6125-137-90 Withdrawn
BRAK6-2590-47 Withdrawn
KOMKM11-2220 Withdrawn
STR2296-3-255 Withdrawn
STR2296-3-506 Withdrawn
KOMEZ1313.M61 Withdrawn
STR5400-134-6 Withdrawn
KOMKMS2513.M61 Withdrawn
STR2108-182-8 Withdrawn
STR5301-110-51 Withdrawn
STR2108-351 Withdrawn
HAL5071-135 Withdrawn
HALK142 Withdrawn
KOMKM3-115 Withdrawn
BRAST4125-127-090 Withdrawn
MICSO-6305 Withdrawn
ARTAR-300-405S Withdrawn
KOMKM-251 Withdrawn
KOMKM-3005 Withdrawn
BRAK6-1290-54 Withdrawn
KOMKM-602 Withdrawn
HAL5023-182 Withdrawn
STR2108-383S1 Withdrawn
BRAST2108-151 Withdrawn
HAL5071-303 Withdrawn
SYN03.000.301 Withdrawn
MICSP-103 Withdrawn
STR277-96-276 Withdrawn
MICZO-072 Withdrawn
HAL5071-344 Withdrawn
HAL5052-135 Withdrawn
MICSO-620 Withdrawn
STR5400-134-281 Withdrawn
SYN05.003.106 Withdrawn
STR2108-318 Withdrawn
STR5100-337-133 Withdrawn
BRAK9-1290-47 Withdrawn
HAL5023-162 Withdrawn
MICMS-122 Withdrawn
HAL5071-534 Withdrawn
STR6113-127-90 Withdrawn
STR2108-383 Withdrawn
SYN03.000.309 Withdrawn
BIO200068 Withdrawn
STR5301-25-41 Withdrawn
KOMKM-22K Withdrawn
STR5400-31-171 Withdrawn
STR298-97-100 Withdrawn
SYN03.000.305 Withdrawn
STR2108-155 Withdrawn
STR2296-31-170 Withdrawn
KOMKM71-550 Withdrawn
STR2296-31-34 Withdrawn
MICSP-125 Withdrawn
STR5400-3-108 Withdrawn
MICZO-7151 Withdrawn
BIO516051 Withdrawn
SYN11-3500 Withdrawn
STR2108-377 Withdrawn
BIO506113 Withdrawn
STR6118-127-90 Withdrawn
STR2296-33-522 Withdrawn
HAL5023-169 Withdrawn
SYN11-3205 Withdrawn
PAD3539-252 Withdrawn
KOMKM-461 Withdrawn
MICZR-154 Withdrawn
ARTAR-300-404S Withdrawn
MICSO-682 Withdrawn
STR2108-152-006 Withdrawn
BRAK6-1990-50 Withdrawn
BRAST4125-135-090 Withdrawn
KOMK-2000-65 Withdrawn
LIN5023-143 Withdrawn
STR2108-110 Withdrawn
KOMKM-3002 Withdrawn
MICZS-342 Withdrawn
BRAST2108-109 Withdrawn
KOMKM-250R Withdrawn
SYN519.114 Withdrawn
DEP5627-14-501 Withdrawn
ZIM699 Withdrawn
HAL5023-137 Withdrawn
STR2108-175 Withdrawn
KOMKM-108 Withdrawn
KOMKM-7556 Withdrawn
KOMKM-13P Withdrawn
HAL5023-132 Withdrawn
STR5100-137-111 Withdrawn
BRAST2108-115 Withdrawn
KOMKM-256 Withdrawn
HAL5072-143 Withdrawn
HALK144 Withdrawn
HAL5071-161 Withdrawn
HAL5023-166 Withdrawn
MICSO6-158 Withdrawn
STR2296-33-234 Withdrawn
SYN11-2222 Withdrawn
SYN519.108 Withdrawn
HAL5023-160 Withdrawn
STR2296-33-114 Withdrawn
MICZS-364 Withdrawn
BRAK6-2590-39F Withdrawn
STR5301-30-171 Withdrawn
HAL5071-562 Withdrawn
STR6118-89-90 Withdrawn
STR2108-151 Withdrawn
STR5301-20-58 Withdrawn
BRAKM33-521 Withdrawn
KOMKM-618 Withdrawn
KOMKM-001 Withdrawn
STR4221-140-090 Withdrawn
HAL5023-144 Withdrawn
MICZS-338 Withdrawn
KOMKM-101 Withdrawn
SYN399.56 Withdrawn
OST450-1019-SP Withdrawn
STR2108-192 Withdrawn
KOMKM-3231 Withdrawn
STR2108-189 Withdrawn
STR4118-119-090 Withdrawn
SYN11-3715 Withdrawn
STR2296-3-515 Withdrawn
SYN11-3706 Withdrawn
SYN519.105 Withdrawn
MICZO-7163 Withdrawn
STR2108-111 Withdrawn
HAL5023-180 Withdrawn
SYN399.570 Withdrawn
STR5400-3-412 Withdrawn
MICZO-7167 Withdrawn
STR2108-102 Withdrawn
STR2296-3-155 Withdrawn
HAL5071-571 Withdrawn
HAL5023-140 Withdrawn
STR6118-97-90 Withdrawn
KOMKM-103C Withdrawn
BRAK9-2590-47 Withdrawn
SYN11-3541 Withdrawn
MICSO-601 Withdrawn
ARTAR-300-402S Withdrawn
STR4113-119-090 Withdrawn
STR2108-351-002 Withdrawn
STR2296-33-115 Withdrawn
STR6118-137-100 Withdrawn
MICMS-121 Withdrawn
HAL5071-132 Withdrawn
MIC1200-005 Withdrawn
KOMKM-675 Withdrawn
STR5400-134-008 Withdrawn
STR5301-25-32 Withdrawn
SYN519.200 Withdrawn
STR5400-3-102 Withdrawn
HAL5053-220 Withdrawn
MICSP-410A Withdrawn
MICSP-412A Withdrawn
KOMKM71-561 Withdrawn
HAL5071-551 Withdrawn
STR2108-376 Withdrawn
HAL5071-201 Withdrawn
DAN211F1SS Withdrawn
BIO506117 Withdrawn
BRABR1-2590-39F Withdrawn
LIN5023-160 Withdrawn
DAN204F1SS Withdrawn
STR2296-3-125 Withdrawn
LINK124 Withdrawn
SYN519.150 Withdrawn
BRAST2108-193 Withdrawn
ZIM5979-95-46 Withdrawn
STR296-34-103 Withdrawn
KOMKM33-105 Withdrawn
STR6125-107-90 Withdrawn
STR4125-147-090 Withdrawn
HAL5071-228 Withdrawn
MICXZS-038 Withdrawn
SYN11-3577 Withdrawn
HAL5071-530 Withdrawn
HAL5059-280 Withdrawn
HAL5071-570-50 Withdrawn
HAL5071-125 Withdrawn
STR2108-182-6 Withdrawn
HAL5071-572 Withdrawn
SYN399.580 Withdrawn
HAL5071-236 Withdrawn
STR6113-127-075 Withdrawn
HAL5071-553 Withdrawn
SYN11-2533 Withdrawn
STR6125-119-90 Withdrawn
MICSP-114A Withdrawn
BRAK6-2590-54F Withdrawn
HALL194 Withdrawn
ZIM190110127LP Withdrawn
MICZS-033 Withdrawn
STR2108-120-009 Withdrawn
DEP5627-87-000 Withdrawn
LIN5023-176 Withdrawn
STR2296-33-108 Withdrawn
KOMKM-41K Withdrawn
STR5400-3-115 Withdrawn
HAL5071-133 Withdrawn
STR2296-31-50 Withdrawn
STR296-31-412 Withdrawn
STR2296-3-254S2 Withdrawn
STR296-31-34 Withdrawn
STR2108-158-2 Withdrawn
STR5305-25-122 Withdrawn
MICZO-72623 Withdrawn

Showing 250 of 300 catalogue numbers.

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
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
Conmed ConMed Corporation 171

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

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2008-08-08 Not classified Packaging process control SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on o 370 2011-04-26

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