Stablecut®
167 catalogue numbers from 964001818, listed by Synvasive Technology, Inc., United States, under Blade, Saw, General & Plastic Surgery, Surgical. 25 manufacturers in China are registered for this product code.
25manufacturers in China registered for this device type
167catalogue numbers in this listing
3recalls on this 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 | Synvasive Technology, Inc., United States |
|---|---|
| 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 | 2017-02-17 |
| Record revised | 2021-01-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 35 to 105 mm; width 6 to 30 mm |
| Distribution end date | 2017-12-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 964001818 | Length 90 mm | In distribution |
| 223502120 | Width 6 mm | In distribution |
| 506116 | Width 13 mm | In distribution |
| 11-3729 | Width 25 mm | In distribution |
| 11-3585 | In distribution | |
| 516014 | Length 90 mm | In distribution |
| 11-2216 | Width 19 mm | In distribution |
| 11-3655 | 0.89mm Thick | In distribution |
| 506078 | In distribution | |
| 11-4681 | Length 90 mm | In distribution |
| 950501595 | 8/13mm W, 1.47mm Thick | In distribution |
| 964006000 | Width 25 mm | In distribution |
| 506128 | 0.89mm Thick | In distribution |
| 506137 | In distribution | |
| 506117 | Width 13 mm | In distribution |
| 11-3674 | In distribution | |
| 506138 | In distribution | |
| 11-4130 | 13/21mm W, 1.37mm Thick | In distribution |
| 506136 | In distribution | |
| 506142 | In distribution | |
| 506079 | In distribution | |
| 223000267 | Small +5 | In distribution |
| 11-4096 | 0.89mm Thick | In distribution |
| 506139 | In distribution | |
| 11-4117 | Length 90 mm | In distribution |
| 11-3582 | In distribution | |
| 964001816 | Width 13 mm | In distribution |
| 964001825 | 1.19mm Thick | In distribution |
| 11-3586 | In distribution | |
| 11-3739 | In distribution | |
| 11-2238 | Length 90 mm | In distribution |
| 506121 | Width 25 mm | In distribution |
| 964001819 | 1.19mm Thick | In distribution |
| 11-4098 | In distribution | |
| 964023000 | Width 25 mm | In distribution |
| 964021100 | Length 90 mm | In distribution |
| 964022000 | 1.47mm Thick | In distribution |
| 11-3768 | In distribution | |
| 506081 | Length 90 mm | In distribution |
| 506298 | In distribution | |
| 11-4024 | Length 75 mm | In distribution |
| 950501594 | Length 70 mm | In distribution |
| 506090 | Width 13 mm | In distribution |
| 964001827 | 1.19mm Thick | In distribution |
| 11-3785 | Length 90 mm | In distribution |
| 506115 | Width 13 mm | In distribution |
| 506111 | In distribution | |
| 11-3944 | Width 6 mm | In distribution |
| 11-4845 | In distribution | |
| 506104 | Length 90 mm | In distribution |
| 223000269 | Large +3 | In distribution |
| 964001821 | Width 25 mm | In distribution |
| 950501593 | Length 70 mm | In distribution |
| 11-4118 | Width 25 mm | In distribution |
| 11-3766 | In distribution | |
| 964001823 | Length 90 mm | In distribution |
| 223000262 | Small +7 | In distribution |
| 223000260 | Small +3 | In distribution |
| 223501120 | Width 6 mm | In distribution |
| 11-3749 | In distribution | |
| 506125 | In distribution | |
| 506085 | Width 13 mm | In distribution |
| 11-3604 | 13/21mm W, 1.37mm Thick | In distribution |
| 506103 | 19/25mm W, 1.37mm Thick | In distribution |
| 506297 | Width 13 mm | In distribution |
| 506094 | Length 90 mm | In distribution |
| 964001826 | Length 90 mm | In distribution |
| 11-3945 | Width 6 mm | In distribution |
| 223000264 | Large +5 | In distribution |
| 506096 | Length 90 mm | In distribution |
| 11-2235 | Width 13 mm | In distribution |
| 11-4137 | 1.19mm Thick | In distribution |
| 11-3759 | 1.47mm Thick | In distribution |
| 964001100 | Length 90 mm | In distribution |
| 223000271 | Large +7 | In distribution |
| 11-4862 | Width 13 mm | In distribution |
| 11-3987 | 0.38mm Thick | In distribution |
| 855540012 | Width 13 mm | In distribution |
| 11-3764 | 0.89mm Thick | In distribution |
| 562782601 | Width 25 mm | In distribution |
| 11-3584 | In distribution | |
| 950501924 | 8/13mm W, 1.47mm Thick | In distribution |
| 11-4151 | Length 65 mm | In distribution |
| 506110 | In distribution | |
| 11-4132 | 13/21mm W, 1.19mm Thick | In distribution |
| 506299 | In distribution | |
| 11-2217 | Width 25 mm | In distribution |
| 11-3583 | In distribution | |
| 964027000 | Length 90 mm | In distribution |
| 506109 | In distribution | |
| 950501591 | Length 70 mm | In distribution |
| 506134 | 1.37mm Thick | In distribution |
| 506088 | Width 13 mm | In distribution |
| 223000265 | Large +7 | In distribution |
| 964001822 | 1.19mm Thick | In distribution |
| 506076 | In distribution | |
| 964001814 | Length 90 mm | In distribution |
| 11-3740 | In distribution | |
| 506086 | Length 90 mm | In distribution |
| 506127 | 1.00/1.19mm Thick | In distribution |
| 11-4844 | In distribution | |
| 506132 | 1.37mm Thick | In distribution |
| 11-3581 | In distribution | |
| 11-3656 | In distribution | |
| 11-3978 | Length 105 mm | In distribution |
| 229910002 | 1.47mm Thick | In distribution |
| 11-3998 | Length 90 mm | In distribution |
| 506124 | In distribution | |
| 506141 | In distribution | |
| 964001824 | Width 25 mm | In distribution |
| 506133 | 1.37mm Thick | In distribution |
| 11-4099 | In distribution | |
| 11-3997 | 1.27mm Thick | In distribution |
| 506112 | Length 70 mm | In distribution |
| 11-3981 | 13/21mm W, 1.27mm Thick | In distribution |
| 506122 | 0.89mm Thick | In distribution |
| 506140 | In distribution | |
| 562756021 | 0.64mm Thick | In distribution |
| 11-3769 | In distribution | |
| 11-3773 | Width 13 mm | In distribution |
| 11-2739 | 13/21mm W, 1.37mm Thick | In distribution |
| 11-3973 | 1.27mm Thick | In distribution |
| 11-2210 | Width 19 mm | In distribution |
| 223000263 | Large +3 | In distribution |
| 506119 | Length 90 mm | In distribution |
| 506131 | Length 105 mm | In distribution |
| 506113 | 1.00/1.19mm Thick | In distribution |
| 950501592 | Length 70 mm | In distribution |
| 964025000 | 1.35mm Thick | In distribution |
| 506092 | 13/21mm W, 1.37mm Thick | In distribution |
| 11-3536 | 0.89mm Thick | In distribution |
| 506105 | Length 90 mm | In distribution |
| 506097 | 0.64mm Thick | In distribution |
| 229910001 | Length 76 mm | In distribution |
| 11-3974 | Length 90 mm | In distribution |
| 11-2618 | Length 90 mm | In distribution |
| 11-4125 | 1.19mm Thick | In distribution |
| 223000270 | Large +5 | In distribution |
| 506082 | Width 25 mm | In distribution |
| 223000266 | Small +3 | In distribution |
| 255593501 | Width 13 mm | In distribution |
| 11-3799 | Width 25 mm | In distribution |
| 11-3770 | In distribution | |
| 506098 | 0.64mm Thick | In distribution |
| 11-4097 | Length 90 mm | In distribution |
| 11-4149 | Length 60 mm | In distribution |
| 964001820 | Length 90 mm | In distribution |
| 223000261 | Small +5 | In distribution |
| 223000268 | Small +7 | In distribution |
| 506089 | 0.89mm Thick | In distribution |
| 964028000 | 1.47mm Thick | In distribution |
| 11-2222 | Length 90 mm | In distribution |
| 506093 | 13/21mm W, 1.37mm Thick | In distribution |
| 950501596 | Length 70 mm | In distribution |
| 964005000 | Width 25 mm | In distribution |
| 964020000 | Length 90 mm | In distribution |
| 11-3742 | Length 90 mm | In distribution |
| 506126 | In distribution | |
| 964026000 | 1.47mm Thick | In distribution |
| 11-2208 | 0.64mm Thick | In distribution |
| 506114 | Width 10 mm | In distribution |
| 855540005 | Width 13 mm | Withdrawn |
| 855540009 | Length 70 mm | Withdrawn |
| 255591000 | Width 13 mm | Withdrawn |
| 855540010 | Width 13 mm | Withdrawn |
| 11-3732 | Length 90 mm | Withdrawn |
| 255591601 | Width 13 mm | Withdrawn |
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 |
| 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
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-07-27 | Class II | Labeling Change Control | Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. | 266 units | 2021-06-07 |
| 2015-12-08 | Class II | Labeling False and Misleading | Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm. | 14 | 2016-11-01 |
| 2013-04-02 | Class II | Packaging process control | Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match t | 3442 units per the part numbers listed | 2014-07-15 |
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.