Blade, Saw, General & Plastic Surgery, Surgical
63.5MM X 0.89 MM Maximum Durability Cast Cutting Segmented Round Oscillating Blade (NON Sterile)
25manufacturers in China registered for this device type
490catalogue numbers in this listing
2510(k) clearances naming this product code
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.
| 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
| Listed by | Omega Surgical Instruments, 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 | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-04 |
| Record revised | 2024-03-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DXS-203 | In distribution | |
| SM-3101 | In distribution | |
| ZHS-1009 | In distribution | |
| OOS-803 | In distribution | |
| SM-1101 | In distribution | |
| ORS-325 | In distribution | |
| SS-102 | In distribution | |
| ZH-574 | In distribution | |
| OP-514 | In distribution | |
| ZHS-051 | In distribution | |
| OOS-855 | In distribution | |
| OU-335 | In distribution | |
| OK-154 | In distribution | |
| MB-17007 | In distribution | |
| OU-336 | In distribution | |
| HM-3010 | In distribution | |
| MB-14004 | In distribution | |
| SS-3514 | In distribution | |
| ORS-275 | In distribution | |
| SM-4506M | In distribution | |
| OK-134 | In distribution | |
| ZH-260 | In distribution | |
| MB-12001 | In distribution | |
| OK-133 | In distribution | |
| ZHS-553 | In distribution | |
| MB-14002 | In distribution | |
| DX-242 | In distribution | |
| SM-3051 | In distribution | |
| DS-87104 | In distribution | |
| OOS-918 | In distribution | |
| OOS-6132 | In distribution | |
| OK-156 | In distribution | |
| DS-87516 | In distribution | |
| OOS-800 | In distribution | |
| ZHS-154 | In distribution | |
| ZMS-3058 | In distribution | |
| SM-4040 | In distribution | |
| ZHS-101 | In distribution | |
| OK-122 | In distribution | |
| ZHS-150 | In distribution | |
| OM-1619 | In distribution | |
| SS-002 | In distribution | |
| ZHS-555 | In distribution | |
| OOS-885 | In distribution | |
| ZMS-133 | In distribution | |
| SM-3412 | In distribution | |
| SS-124 | In distribution | |
| ZMS-183 | In distribution | |
| SM-4513 | In distribution | |
| DX-223 | In distribution | |
| MB-17012 | In distribution | |
| OOS-156 | In distribution | |
| OOS-14258 | In distribution | |
| OL-216 | In distribution | |
| DS-80206 | In distribution | |
| AGC-912 | In distribution | |
| DXS-210 | In distribution | |
| SM-3809 | In distribution | |
| OP-513 | In distribution | |
| ZHS-578 | In distribution | |
| DX-261 | In distribution | |
| SY-975 | In distribution | |
| SM-3105 | In distribution | |
| SSE-2590 | In distribution | |
| ZMS-132 | In distribution | |
| SM-4050 | In distribution | |
| A060-10 | In distribution | |
| ZM-260D | In distribution | |
| ZH-056 | In distribution | |
| MB-14001 | In distribution | |
| OOS-852 | In distribution | |
| DS-87100 | In distribution | |
| ZH-258 | In distribution | |
| OOS-802 | In distribution | |
| SM-3102 | In distribution | |
| HM-2010 | In distribution | |
| SM-6411 | In distribution | |
| ZHS-305 | In distribution | |
| CC6-001 | In distribution | |
| SM-4055 | In distribution | |
| MB-12014 | In distribution | |
| DX6-268 | In distribution | |
| DX-245 | In distribution | |
| ZST-279 | In distribution | |
| SM-1413 | In distribution | |
| ZM-052 | In distribution | |
| ZM-170 | In distribution | |
| SM-6410 | In distribution | |
| ZHS-272 | In distribution | |
| AGC-010 | In distribution | |
| OMM-8201 | In distribution | |
| ZM-262 | In distribution | |
| DX-225 | In distribution | |
| OL-125 | In distribution | |
| ZH-101 | In distribution | |
| DX-244 | In distribution | |
| AGC-2803 | In distribution | |
| ZHS-552 | In distribution | |
| OOS-109 | In distribution | |
| OOS-897 | In distribution | |
| SS-230 | In distribution | |
| ZH-203 | In distribution | |
| ZH-90119 | In distribution | |
| DX-262 | In distribution | |
| SS-114 | In distribution | |
| ZHS-561 | In distribution | |
| SS-115 | In distribution | |
| ZM-238S | In distribution | |
| ORS-027 | In distribution | |
| OK-123 | In distribution | |
| DX-266 | In distribution | |
| ZH-577 | In distribution | |
| ZHS-530 | In distribution | |
| SSE-2419 | In distribution | |
| ZM-081 | In distribution | |
| OOS-858 | In distribution | |
| SM-1410 | In distribution | |
| ZMS-137 | In distribution | |
| DS-80102 | In distribution | |
| ORST-134 | In distribution | |
| MB-12018 | In distribution | |
| OOS-115 | In distribution | |
| AGC-777R | In distribution | |
| AGE-241 | In distribution | |
| OOS-137 | In distribution | |
| ZHS-054K | In distribution | |
| ZHS-554 | In distribution | |
| HM-2030 | In distribution | |
| ZMS-027 | In distribution | |
| ZH-100 | In distribution | |
| SM-1417 | In distribution | |
| OOS-982 | In distribution | |
| OOS-844 | In distribution | |
| ZM-020 | In distribution | |
| MB-12013 | In distribution | |
| OOS-175 | In distribution | |
| OD-412 | In distribution | |
| SSE-1855 | In distribution | |
| DXS-201 | In distribution | |
| SM-5009-01 | In distribution | |
| OK-5009 | In distribution | |
| OOS-105 | In distribution | |
| HM-3050 | In distribution | |
| OL-158 | In distribution | |
| ZHS-201 | In distribution | |
| ZH-259 | In distribution | |
| OL-305 | In distribution | |
| ORS-028 | In distribution | |
| MB-12008 | In distribution | |
| DX6-266 | In distribution | |
| MB-12006 | In distribution | |
| SM-3106 | In distribution | |
| ZM-051 | In distribution | |
| AGC-553 | In distribution | |
| MB-17010 | In distribution | |
| SM-6412 | In distribution | |
| OOS-851 | In distribution | |
| SM-4011M | In distribution | |
| OK-149 | In distribution | |
| SM-4011 | In distribution | |
| ZH-205 | In distribution | |
| OOS-120 | In distribution | |
| OOS-160 | In distribution | |
| SM-1415 | In distribution | |
| OA-566R | In distribution | |
| CC940-23 | In distribution | |
| CC2-0X | In distribution | |
| OL-205L | In distribution | |
| SM-1103 | In distribution | |
| ZH-102 | In distribution | |
| ZMS-118 | In distribution | |
| ZMS-3514 | In distribution | |
| SS-108 | In distribution | |
| ZM-050 | In distribution | |
| SM-1411 | In distribution | |
| DXS-206 | In distribution | |
| AGC-030 | In distribution | |
| ZHS-145 | In distribution | |
| OM-1027 | In distribution | |
| OL-135 | In distribution | |
| DX6-261 | In distribution | |
| SM-5009-01NS | In distribution | |
| SM-3809NS | In distribution | |
| MB-12011 | In distribution | |
| SM-2419 | In distribution | |
| OOS-125 | In distribution | |
| OP-510 | In distribution | |
| OK-152 | In distribution | |
| DXS-202 | In distribution | |
| DS-80109 | In distribution | |
| SSE-4095 | In distribution | |
| DS-80103 | In distribution | |
| MB-17002 | In distribution | |
| MB-12010 | In distribution | |
| OOS-892 | In distribution | |
| OOS-825 | In distribution | |
| OOS-110 | In distribution | |
| OOS-820 | In distribution | |
| OOS-889 | In distribution | |
| SM-3410 | In distribution | |
| AGC-020 | In distribution | |
| OK-155 | In distribution | |
| ZH-250 | In distribution | |
| ZHS-1101 | In distribution | |
| OOS-810 | In distribution | |
| MB-12019 | In distribution | |
| ZM-027 | In distribution | |
| ZHS-595 | In distribution | |
| ZM-260 | In distribution | |
| ZMS-138 | In distribution | |
| OOS-118 | In distribution | |
| OL-138 | In distribution | |
| SM-4006 | In distribution | |
| SS-103 | In distribution | |
| DCC-635-25 | In distribution | |
| OOS-831 | In distribution | |
| SM-3108 | In distribution | |
| MB-14003 | In distribution | |
| OOS-130 | In distribution | |
| ZM-266 | In distribution | |
| OL-126 | In distribution | |
| ORST-323R | In distribution | |
| OOS-150 | In distribution | |
| ZMS-4006 | In distribution | |
| CC2-0 | In distribution | |
| ZM-241 | In distribution | |
| OOS-837 | In distribution | |
| SS-201 | In distribution | |
| MB-12007 | In distribution | |
| SM-1412 | In distribution | |
| CC1-001 | In distribution | |
| DXS-205 | In distribution | |
| SSM-064 | In distribution | |
| OOS-895 | In distribution | |
| ZMS-3109 | In distribution | |
| SSM-048 | In distribution | |
| ZM-171 | In distribution | |
| SM-3206 | In distribution | |
| OA-631R | In distribution | |
| OOS-845 | In distribution | |
| MB-17008 | In distribution | |
| DX-203 | In distribution | |
| OOS-805 | In distribution | |
| SM-4051 | In distribution | |
| OL-132 | In distribution | |
| SM-3819 | In distribution | |
| DX-222 | In distribution | |
| OOS-840 | In distribution | |
| SM-3114 | In distribution | |
| SYR-327 | In distribution |
Showing 250 of 300 catalogue numbers.
Same 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K933595 | 1994-03-16 |
| K933298 | 1993-08-09 |
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.