Blade, Saw, General & Plastic Surgery, Surgical
Dr. Johansen Aggressive 2108 Series Sagittal Blade Flared (25.0 x 0.97 x 89.4mm)
25manufacturers in China registered for this device type
430catalogue numbers in this listing
2recalls 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 | Stryker GmbH, Switzerland |
|---|---|
| FDA product code | GFA |
| Device type | Blade, Saw, General & Plastic Surgery, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-23 |
| Record revised | 2022-01-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| Sizes | Depth 3.7 to 110 mm; length 61.7 to 80.95 mm; angle 40 to 60 °; length 11 cm |
| Distribution end date | 2021-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4111119090 | Material Thickness: 1.04 Millimeter | In distribution |
| 2108193000 | Depth 82.1 mm | In distribution |
| 2108192000S1 | Cut Edge: 29.6 Millimeter | In distribution |
| 2108183000 | Cut Edge: 28.9 Millimeter | In distribution |
| 5400031053 | Cut Edge: 12.0 Millimeter | In distribution |
| 5301025039 | Depth 25.5 mm | In distribution |
| 2108182006S1 | Depth 86.0 mm | In distribution |
| 2108152002 | Depth 61.5 mm | In distribution |
| 2108145000 | Cut Edge: 9.1 Millimeter | In distribution |
| 2296033414S2 | Angle 45.0 ° | In distribution |
| 2108115000 | Cut Edge: 18.6 Millimeter | In distribution |
| 2296003506 | Material Thickness: 0.38 Millimeter | In distribution |
| 5400031172 | Depth 32.0 mm | In distribution |
| 5301025032 | Cut Edge: 6.0 Millimeter | In distribution |
| 4135089064 | Depth 64.0 mm | In distribution |
| 5400134281 | Cut Thickness: 0.64 Millimeter | In distribution |
| 2108383000 | Depth 83.5 mm | In distribution |
| 5100137133 | Cut Edge: 22.5 Millimeter | In distribution |
| 5400003194 | Cut Edge: 7.0 Millimeter | In distribution |
| 2296033105 | Cut Edge: 9.0 Millimeter | In distribution |
| 5400031416 | Material Thickness: 0.51 Millimeter | In distribution |
| 4118135105S1 | Material Thickness: 1.19 Millimeter | In distribution |
| 2108146000 | Cut Thickness: 1.12 Millimeter | In distribution |
| 5400003103 | Cut Thickness: 0.5 Millimeter | In distribution |
| 2296023412 | Cut Edge: 5.5 Millimeter | In distribution |
| 2108352000 | Cut Edge: 12.5 Millimeter | In distribution |
| 2296033220 | Cut Edge: 9.0 Millimeter | In distribution |
| 4218127090 | Cut Edge: 18.0 Millimeter | In distribution |
| 0290628000 | Diameter: 2.5 Millimeter | In distribution |
| 2296003108S5 | Depth 50.0 mm | In distribution |
| 5400003254S1 | Depth 50.0 mm | In distribution |
| 2108109000S16 | Material Thickness: 1.27 Millimeter | In distribution |
| 2108152000S5 | Material Thickness: 0.88 Millimeter | In distribution |
| 2108103000 | Cut Thickness: 0.94 Millimeter | In distribution |
| 5100337134 | Cut Thickness: 0.53 Millimeter | In distribution |
| 4218147060 | Material Thickness: 1.47 Millimeter | In distribution |
| 2296033520 | Depth 35.0 mm | In distribution |
| 2296003051S2 | Material Thickness: 0.38 Millimeter | In distribution |
| 0277096300 | Depth 6.2 mm | In distribution |
| 2108110006 | Cut Edge: 25.0 Millimeter | In distribution |
| 4118089090 | Cut Edge: 18.0 Millimeter | In distribution |
| 2108393000S4 | Cut Edge: 25.0 Millimeter | In distribution |
| 5100137233 | Cut Edge: 27.0 Millimeter | In distribution |
| 2296031034 | Material Thickness: 0.38 Millimeter | In distribution |
| 5100137012 | Cut Thickness: 0.53 Millimeter | In distribution |
| 4125127100 | Depth 100.0 mm | In distribution |
| 2108130001 | Cut Edge: 25.0 Millimeter | In distribution |
| 2108107004S1 | Material Thickness: 1.19 Millimeter | In distribution |
| 2296033521 | Cut Thickness: 0.76 Millimeter | In distribution |
| 2296033414 | Depth 25.0 mm | In distribution |
| 5301030060 | Cut Thickness: 0.6 Millimeter | In distribution |
| 2108109001S1 | Material Thickness: 0.88 Millimeter | In distribution |
| 2296033108 | Material Thickness: 0.51 Millimeter | In distribution |
| 2296003151 | Depth 11.0 mm | In distribution |
| 2108107000S8 | Material Thickness: 0.88 Millimeter | In distribution |
| 5400003414 | Cut Thickness: 0.33 Millimeter | In distribution |
| 2108148000S8 | Cut Thickness: 0.76 Millimeter | In distribution |
| 2108111000 | Cut Edge: 24.8 Millimeter | In distribution |
| 2108318000 | Cut Edge: 25.0 Millimeter | In distribution |
| 5100037901S2 | Cut Thickness: 0.58 Millimeter | In distribution |
| 5301025043 | Depth 25.5 mm | In distribution |
| 2296003414S4 | Cut Thickness: 0.61 Millimeter | In distribution |
| 2296033526 | Depth 39.0 mm | In distribution |
| 4111147075 | Depth 75.0 mm | In distribution |
| 0277031416 | Depth 25.5 mm | In distribution |
| 2108144000 | Cut Thickness: 0.76 Millimeter | In distribution |
| 2108328000 | Material Thickness: 1.24 Millimeter | In distribution |
| 5100037902S2 | Depth 4.95 mm | In distribution |
| 2296003106S3 | Material Thickness: 0.25 Millimeter | In distribution |
| 2296003150 | Cut Edge: 9.0 Millimeter | In distribution |
| 2108109001 | Cut Edge: 20.5 Millimeter | In distribution |
| 0277096325 | Material Thickness: 0.77 Millimeter | In distribution |
| 5100137020 | Cut Thickness: 0.53 Millimeter | In distribution |
| 2296003255 | Depth 18.5 mm | In distribution |
| 4118089075 | Cut Edge: 18.0 Millimeter | In distribution |
| 0290645000 | Diameter: 4.0 Millimeter | In distribution |
| 4118127090 | Depth 90.0 mm | In distribution |
| 0277096277 | Material Thickness: 1.0 Millimeter | In distribution |
| 4111127090 | Material Thickness: 1.13 Millimeter | In distribution |
| 5400003520 | Depth 35.0 mm | In distribution |
| 2108151001 | Cut Edge: 25.0 Millimeter | In distribution |
| 2108109003 | Cut Edge: 20.0 Millimeter | In distribution |
| 2296003102S2 | Material Thickness: 0.25 Millimeter | In distribution |
| 0277096275 | Cut Thickness: 0.91 Millimeter | In distribution |
| 5400031171 | Cut Thickness: 0.66 Millimeter | In distribution |
| 2108107005 | Cut Edge: 29.0 Millimeter | In distribution |
| 5100037012 | Material Thickness: 0.64 Millimeter | In distribution |
| 2108183003 | Cut Edge: 29.0 Millimeter | In distribution |
| 2108136000S4 | Material Thickness: 0.38 Millimeter | In distribution |
| 2108140000 | Depth 58.7 mm | In distribution |
| 2296033101 | Material Thickness: 0.51 Millimeter | In distribution |
| 2108189000 | Material Thickness: 1.27 Millimeter | In distribution |
| 2108376000 | Cut Edge: 25.0 Millimeter | In distribution |
| 4118127075 | Depth 75.0 mm | In distribution |
| 2108109004 | Cut Edge: 20.5 Millimeter | In distribution |
| 2108185001 | Material Thickness: 1.24 Millimeter | In distribution |
| 2108140000S2 | Cut Thickness: 1.02 Millimeter | In distribution |
| 2108393005 | Depth 89.5 mm | In distribution |
| 2108150000S2 | Depth 48.5 mm | In distribution |
| 0277096276S1 | Material Thickness: 0.77 Millimeter | In distribution |
| 4221140090 | Material Thickness: 1.4 Millimeter | In distribution |
| 5100037011 | Cut Edge: 14.5 Millimeter | In distribution |
| 2296031171 | Cut Edge: 13.5 Millimeter | In distribution |
| 2108110002 | Cut Edge: 25.0 Millimeter | In distribution |
| 2296033111 | Cut Edge: 9.0 Millimeter | In distribution |
| 2108382000S4 | Depth 83.5 mm | In distribution |
| 0277031416S1 | Cut Thickness: 0.53 Millimeter | In distribution |
| 2108177001 | Material Thickness: 1.32 Millimeter | In distribution |
| 2296031050 | Cut Thickness: 0.51 Millimeter | In distribution |
| 2108152000S7 | Cut Edge: 12.5 Millimeter | In distribution |
| 2296003104 | Depth 34.5 mm | In distribution |
| 0277096281 | Cut Thickness: 1.4 Millimeter | In distribution |
| 2108105000 | Cut Thickness: 0.93 Millimeter | In distribution |
| 2108161002 | Cut Thickness: 1.49 Millimeter | In distribution |
| 2108109000S8 | Material Thickness: 0.94 Millimeter | In distribution |
| 5400003411 | Depth 11.5 mm | In distribution |
| 5400031032 | Cut Thickness: 0.51 Millimeter | In distribution |
| 4118135105 | Depth 105.0 mm | In distribution |
| 2296003254 | Material Thickness: 0.38 Millimeter | In distribution |
| 2108131000S2 | Cut Edge: 17.0 Millimeter | In distribution |
| 4118127100 | Cut Edge: 18.0 Millimeter | In distribution |
| 2108150000S8 | Cut Thickness: 0.61 Millimeter | In distribution |
| 0277096327 | Cut Thickness: 1.09 Millimeter | In distribution |
| 5400031050 | Cut Edge: 9.0 Millimeter | In distribution |
| 5301030073 | Material Thickness: 0.4 Millimeter | In distribution |
| 2108109000S17 | Material Thickness: 1.2 Millimeter | In distribution |
| 2108120009 | Cut Edge: 18.5 Millimeter | In distribution |
| 2873005001 | Depth 18.4 mm | In distribution |
| 2108393006 | Material Thickness: 0.96 Millimeter | In distribution |
| 2296033234 | Depth 9.0 mm | In distribution |
| 2108309000 | Cut Edge: 21.0 Millimeter | In distribution |
| 2108109000S15 | Cut Edge: 19.5 Millimeter | In distribution |
| 4125147090S3 | Cut Edge: 24.5 Millimeter | In distribution |
| 5301035020 | Cut Edge: 25.4 Millimeter | In distribution |
| 5301030062 | Material Thickness: 0.4 Millimeter | In distribution |
| 0290011000 | Length 11.0 cm | In distribution |
| 2108305000 | Depth 73.0 mm | In distribution |
| 2108183001 | Depth 84.0 mm | In distribution |
| 5100137106 | Material Thickness: 0.38 Millimeter | In distribution |
| 2296003206 | Material Thickness: 0.38 Millimeter | In distribution |
| 5100137123 | Cut Thickness: 0.53 Millimeter | In distribution |
| 2108120000 | Cut Edge: 18.6 Millimeter | In distribution |
| 2296003508 | Cut Edge: 13.0 Millimeter | In distribution |
| 2108218000 | Material Thickness: 1.24 Millimeter | In distribution |
| 2296003214 | Cut Edge: 19.0 Millimeter | In distribution |
| 5100337121 | Cut Thickness: 0.51 Millimeter | In distribution |
| 2296003121 | Depth 12.0 mm | In distribution |
| 5301020061S1 | Material Thickness: 1.27 Millimeter | In distribution |
| 11-3922 | In distribution | |
| 5400003102 | Depth 18.5 mm | In distribution |
| 2108389000 | Cut Edge: 25.0 Millimeter | In distribution |
| 2108113000 | Material Thickness: 1.24 Millimeter | In distribution |
| 5100337123 | Cut Edge: 27.0 Millimeter | In distribution |
| 0290638000 | Diameter: 3.5 Millimeter | In distribution |
| 2108385000 | Cut Edge: 18.5 Millimeter | In distribution |
| 2296033111S8 | Cut Edge: 9.2 Millimeter | In distribution |
| 2296003515 | Depth 42.0 mm | In distribution |
| 2108377000 | Cut Edge: 25.0 Millimeter | In distribution |
| 2108176002 | Material Thickness: 1.47 Millimeter | In distribution |
| 2108120000S7 | Depth 61.0 mm | In distribution |
| 4118137090 | Material Thickness: 1.23 Millimeter | In distribution |
| 2296031052 | Cut Thickness: 0.51 Millimeter | In distribution |
| 2296003155 | Depth 18.5 mm | In distribution |
| 2296033411 | Cut Edge: 9.0 Millimeter | In distribution |
| 5100137011 | Cut Edge: 14.5 Millimeter | In distribution |
| 2108182000S16 | Cut Edge: 18.5 Millimeter | In distribution |
| 2108156000 | Cut Thickness: 1.38 Millimeter | In distribution |
| 5400031034 | Depth 12.0 mm | In distribution |
| 2296003114 | Depth 18.5 mm | In distribution |
| 5100137134S1 | Cut Thickness: 0.38 Millimeter | In distribution |
| 2296003125S9 | Material Thickness: 0.38 Millimeter | In distribution |
| 5400134284 | Cut Edge: 20.0 Millimeter | In distribution |
| 2108302000 | Material Thickness: 0.89 Millimeter | In distribution |
| 2296003221 | Depth 12.0 mm | In distribution |
| 2296003115S5 | Depth 25.0 mm | In distribution |
| 5400031417 | Depth 30.0 mm | In distribution |
| 5301025038 | Cut Edge: 9.5 Millimeter | In distribution |
| 2296003212 | Depth 18.0 mm | In distribution |
| 5400003115 | Cut Thickness: 0.5 Millimeter | In distribution |
| 0277096326 | Depth 11.0 mm | In distribution |
| 2108109000S13 | Cut Thickness: 0.99 Millimeter | In distribution |
| 2108351000 | Depth 85.0 mm | In distribution |
| 2108382001S2 | Depth 100.5 mm | In distribution |
| 5400003114 | Cut Edge: 7.0 Millimeter | In distribution |
| 2296003111S5 | Cut Edge: 8.8 Millimeter | In distribution |
| 2296033102 | Cut Edge: 16.5 Millimeter | In distribution |
| 2108382002 | Depth 90.0 mm | In distribution |
| 4125089090 | Material Thickness: 0.8 Millimeter | In distribution |
| 4118127090S3 | Cut Thickness: 1.28 Millimeter | In distribution |
| 2108182000S9 | Material Thickness: 1.24 Millimeter | In distribution |
| 2108393000S7 | Cut Edge: 25.0 Millimeter | In distribution |
| 4118107090 | Material Thickness: 0.97 Millimeter | In distribution |
| 4118147090 | Cut Edge: 18.0 Millimeter | In distribution |
| 2108118000 | Depth 80.1 mm | In distribution |
| 2296033522 | Cut Edge: 9.0 Millimeter | In distribution |
| 0277096251 | Cut Edge: 47.5 Millimeter | In distribution |
| 5400003111 | Cut Edge: 9.0 Millimeter | In distribution |
| 2296031417 | Material Thickness: 0.51 Millimeter | In distribution |
| 2108158000 | Material Thickness: 1.27 Millimeter | In distribution |
| 5400003108 | Cut Edge: 13.0 Millimeter | In distribution |
| 2296023105 | Depth 18.5 mm | In distribution |
| 5100037901 | Material Thickness: 0.38 Millimeter | In distribution |
| 2296003528 | Material Thickness: 0.38 Millimeter | In distribution |
| 2108109000S11 | Depth 90.0 mm | In distribution |
| 2296003525 | Material Thickness: 0.38 Millimeter | In distribution |
| 11-3925 | In distribution | |
| 2108148000 | Cut Edge: 9.1 Millimeter | In distribution |
| 2296003102 | Cut Edge: 16.5 Millimeter | In distribution |
| 4111089075 | Cut Edge: 11.0 Millimeter | In distribution |
| 2296003529 | Material Thickness: 0.38 Millimeter | In distribution |
| 2296033519 | Cut Edge: 9.0 Millimeter | In distribution |
| 4211127075 | Cut Edge: 11.0 Millimeter | In distribution |
| 5100037903 | Cut Thickness: 0.51 Millimeter | In distribution |
| 2296033106 | Cut Edge: 13.0 Millimeter | In distribution |
| 2108107004 | Depth 64.0 mm | In distribution |
| 2108197000 | Depth 61.7 mm | In distribution |
| 4125089075 | Cut Thickness: 0.89 Millimeter | In distribution |
| 11-3924 | In distribution | |
| 5302025038 | Material Thickness: 0.4 Millimeter | In distribution |
| 5400031032S1 | Material Thickness: 0.381 Millimeter | In distribution |
| 5400134279 | Cut Thickness: 0.64 Millimeter | In distribution |
| 5100337133S1 | Length 68.2 mm | In distribution |
| 2296003105 | Depth 18.5 mm | In distribution |
| 5301030063 | Depth 18.5 mm | In distribution |
| 5100037020 | Cut Thickness: 1.02 Millimeter | In distribution |
| 2108393005S2 | Thickness: 0.99 Millimeter | In distribution |
| 2296033413 | Cut Edge: 2.5 Millimeter | In distribution |
| 2296033103 | Cut Edge: 7.0 Millimeter | In distribution |
| 5400134415 | Depth 41.5 mm | In distribution |
| 2296023111 | Material Thickness: 0.254 Millimeter | In distribution |
| 2296003106 | Cut Edge: 13.0 Millimeter | In distribution |
| 0277096278 | Material Thickness: 0.96 Millimeter | In distribution |
| 2296003254S2 | Material Thickness: 0.51 Millimeter | In distribution |
| 5400003125 | Depth 31.0 mm | In distribution |
| 5301010072 | Depth 71.0 mm | In distribution |
| 2108310000 | Depth 73.0 mm | In distribution |
| 4118119090 | Material Thickness: 1.04 Millimeter | In distribution |
| 2296003410 | Material Thickness: 0.38 Millimeter | In distribution |
| 2108183013 | Depth 99.0 mm | In distribution |
| 2108197000S4 | Depth 70.0 mm | In distribution |
| 5400031176 | Material Thickness: 0.38 Millimeter | In distribution |
| 0277096250 | Material Thickness: 0.64 Millimeter | In distribution |
| 2108160000 | Cut Thickness: 1.27 Millimeter | In distribution |
| 2296033125 | Depth 31.0 mm | In distribution |
| 5305010124S2 | Depth 61.5 mm | In distribution |
| 4125064075 | Material Thickness: 0.51 Millimeter | In distribution |
| 2108110000 | Cut Edge: 24.8 Millimeter | In distribution |
| 2296003124 | Depth 43.0 mm | In distribution |
| 5301020073 | Material Thickness: 0.64 Millimeter | In distribution |
| 1106000000 | Cut Edge: 20.0 Millimeter | 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 |
| Blade, Saw, General & Plastic Surgery, Surgical | Omega Surgical Instruments, Inc. | 490 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 438 |
| 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 Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stryker Instruments | UDI-DI | 2025-01-08 | Class II | Process control | Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece. | 622 units |
| Stryker Instruments | UDI-DI | 2025-01-08 | Class II | Process control | Precision Thin blade attachments have a potential to be out of measurement specifications, preventing them from securely fitting into the compatible handpiece. | 238 units |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2019-03-19 | Class II | Under Investigation by firm | During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility. | 355 | 2020-06-26 |
| 2011-06-13 | Not classified | Labeling mix-ups | Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle. | 95 Units | 2011-08-03 |
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.