Masada
Egps, Screw Shank Driver V2, Cannulated, T27
5manufacturers in China registered for this device type
335catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Astura Medical, United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2024-04-08 |
| Record revised | 2025-12-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 20 to 120 mm; outer diameter 4 to 10.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NBA085090 | Length 90 mm | In distribution |
| NBG060040 | Length 40 mm | In distribution |
| NBA100100 | Length 100 mm | In distribution |
| NBA095110 | Length 110 mm | In distribution |
| NBH065065 | Length 65 mm | In distribution |
| NBA090020 | Length 20 mm | In distribution |
| NZA024050 | In distribution | |
| NZA024070 | In distribution | |
| NBG050060 | Length 60 mm | In distribution |
| NBG040050 | Length 50 mm | In distribution |
| NBH075110 | Length 110 mm | In distribution |
| NZA024100 | Length 60 mm | In distribution |
| NBG080080 | Length 80 mm | In distribution |
| NBA080060 | Length 60 mm | In distribution |
| NBA085030 | Length 30 mm | In distribution |
| NZA024070 | Length 60 mm | In distribution |
| NBA090025 | Length 25 mm | In distribution |
| NBA090115 | Length 115 mm | In distribution |
| NBH075065 | Length 65 mm | In distribution |
| NBA075100 | Length 100 mm | In distribution |
| NBG055050 | Length 50 mm | In distribution |
| NBG045040 | Length 40 mm | In distribution |
| NBG050055 | Length 55 mm | In distribution |
| NBG075035 | Length 35 mm | In distribution |
| NBA085050 | Length 50 mm | In distribution |
| NBA100070 | Length 70 mm | In distribution |
| NZA024060 | Length 60 mm | In distribution |
| NBA080040 | Length 40 mm | In distribution |
| NBH070040 | Length 40 mm | In distribution |
| NBH070045 | Length 45 mm | In distribution |
| NBG040025 | Length 25 mm | In distribution |
| NBG040060 | Length 60 mm | In distribution |
| NZA024095 | Length 60 mm | In distribution |
| NBA090100 | Length 100 mm | In distribution |
| NBA075105 | Length 105 mm | In distribution |
| NBA090060 | Length 60 mm | In distribution |
| NBA100080 | Length 80 mm | In distribution |
| NBA090075 | Length 75 mm | In distribution |
| NBA085085 | Length 85 mm | In distribution |
| NBH080085 | Length 85 mm | In distribution |
| NBH080055 | Length 55 mm | In distribution |
| NBA085115 | Length 115 mm | In distribution |
| NBH080030 | Length 30 mm | In distribution |
| NBA085035 | Length 35 mm | In distribution |
| NBA105060 | Length 60 mm | In distribution |
| NBA095085 | Length 85 mm | In distribution |
| NBA085105 | Length 105 mm | In distribution |
| NBH075055 | Length 55 mm | In distribution |
| NBG080030 | Length 30 mm | In distribution |
| NBA090105 | Length 105 mm | In distribution |
| NBG045035 | Length 35 mm | In distribution |
| NBA100055 | Length 55 mm | In distribution |
| NBG070055 | Length 55 mm | In distribution |
| NBA105100 | Length 100 mm | In distribution |
| NBG045055 | Length 55 mm | In distribution |
| NBA075070 | Length 70 mm | In distribution |
| NBG065040 | Length 40 mm | In distribution |
| NBA095070 | Length 70 mm | In distribution |
| NBA075110 | Length 110 mm | In distribution |
| NBA080045 | Length 45 mm | In distribution |
| NBA100045 | Length 45 mm | In distribution |
| NBA095020 | Length 20 mm | In distribution |
| NBA100060 | Length 60 mm | In distribution |
| NBG060055 | Length 55 mm | In distribution |
| NBG075030 | Length 30 mm | In distribution |
| NZA025000 | Length 60 mm | In distribution |
| NBG050050 | Length 50 mm | In distribution |
| NBH080035 | Length 35 mm | In distribution |
| NBA080075 | Length 75 mm | In distribution |
| NBH080075 | Length 75 mm | In distribution |
| NBA070090 | Length 90 mm | In distribution |
| NZA024090 | Length 60 mm | In distribution |
| NBH080090 | Length 90 mm | In distribution |
| NBA095045 | Length 45 mm | In distribution |
| NBH085060 | Length 60 mm | In distribution |
| NBA070120 | Length 120 mm | In distribution |
| NBG040030 | Length 30 mm | In distribution |
| NBG045025 | Length 25 mm | In distribution |
| NBA090050 | Length 50 mm | In distribution |
| NBA080035 | Length 35 mm | In distribution |
| NBA090045 | Length 45 mm | In distribution |
| NBA085025 | Length 25 mm | In distribution |
| NBG045030 | Length 30 mm | In distribution |
| NBA090085 | Length 85 mm | In distribution |
| NBH080065 | Length 65 mm | In distribution |
| NBA075050 | Length 45 mm | In distribution |
| NBA095075 | Length 75 mm | In distribution |
| NBA090030 | Length 30 mm | In distribution |
| NBG075040 | Length 40 mm | In distribution |
| NBG080050 | Length 50 mm | In distribution |
| NBG045060 | Length 60 mm | In distribution |
| NZA033001 | Length 60 mm | In distribution |
| NZA024105 | Length 60 mm | In distribution |
| NBA090110 | Length 110 mm | In distribution |
| NBA075075 | Length 75 mm | In distribution |
| NBH065040 | Length 40 mm | In distribution |
| NBH080115 | Length 115 mm | In distribution |
| NBA080110 | Length 110 mm | In distribution |
| NBA105030 | Length 30 mm | In distribution |
| NBH065060 | Length 60 mm | In distribution |
| NBH085050 | Length 50 mm | In distribution |
| NBH085055 | Length 55 mm | In distribution |
| NBH070050 | Length 50 mm | In distribution |
| NBG075060 | Length 60 mm | In distribution |
| NBG060030 | Length 30 mm | In distribution |
| NBH075115 | Length 115 mm | In distribution |
| NBG070035 | Length 35 mm | In distribution |
| NBG065050 | Length 50 mm | In distribution |
| NBA100095 | Length 95 mm | In distribution |
| NBA080070 | Length 70 mm | In distribution |
| NBG065060 | Length 60 mm | In distribution |
| NBH080100 | Length 100 mm | In distribution |
| NBG050025 | Length 25 mm | In distribution |
| NBH080110 | Length 110 mm | In distribution |
| NBA100110 | Length 110 mm | In distribution |
| NBA095030 | Length 30 mm | In distribution |
| NBA080090 | Length 90 mm | In distribution |
| NBH075045 | Length 45 mm | In distribution |
| NBG070030 | Length 30 mm | In distribution |
| NBA090040 | Length 40 mm | In distribution |
| NBH070030 | Length 30 mm | In distribution |
| NBA100120 | Length 120 mm | In distribution |
| NBH085080 | Length 80 mm | In distribution |
| NBA105110 | Length 110 mm | In distribution |
| NBA070115 | Length 115 mm | In distribution |
| NBH075080 | Length 80 mm | In distribution |
| NZA024055 | In distribution | |
| NBH085090 | Length 90 mm | In distribution |
| NBG060045 | Length 45 mm | In distribution |
| NBG075110 | Length 110 mm | In distribution |
| NBA100040 | Length 40 mm | In distribution |
| NBH080060 | Length 60 mm | In distribution |
| NBG080070 | Length 70 mm | In distribution |
| NZA024055 | Length 60 mm | In distribution |
| NBG080035 | Length 35 mm | In distribution |
| NBA100030 | Length 30 mm | In distribution |
| NBH075090 | Length 90 mm | In distribution |
| NBH085035 | Length 35 mm | In distribution |
| NBA105120 | Length 120 mm | In distribution |
| NBG040045 | Length 45 mm | In distribution |
| NBG065030 | Length 30 mm | In distribution |
| NBA080085 | Length 85 mm | In distribution |
| NBA085075 | Length 75 mm | In distribution |
| NBA090120 | Length 120 mm | In distribution |
| NBG055045 | Length 45 mm | In distribution |
| NBH085065 | Length 65 mm | In distribution |
| NBA105115 | Length 115 mm | In distribution |
| NBA095105 | Length 105 mm | In distribution |
| NBA095090 | Length 90 mm | In distribution |
| NBG065035 | Length 35 mm | In distribution |
| NBA075090 | Length 90 mm | In distribution |
| NBA100085 | Length 85 mm | In distribution |
| NBA090055 | Length 55 mm | In distribution |
| NBG060025 | Length 25 mm | In distribution |
| NZA033000 | Length 60 mm | In distribution |
| NBA075045 | Length 45 mm | In distribution |
| NBG055020 | Length 20 mm | In distribution |
| NBG040020 | Length 20 mm | In distribution |
| NBA095100 | Length 100 mm | In distribution |
| NBA100065 | Length 65 mm | In distribution |
| NBA070095 | Length 95 mm | In distribution |
| NBG055030 | Length 30 mm | In distribution |
| NBG055035 | Length 35 mm | In distribution |
| NBG075085 | Length 85 mm | In distribution |
| NBA085020 | Length 20 mm | In distribution |
| NBA105075 | Length 75 mm | In distribution |
| NBA075020 | Length 20 mm | In distribution |
| NZA024050 | Length 60 mm | In distribution |
| NZA024045 | Length 60 mm | In distribution |
| NBG060020 | Length 20 mm | In distribution |
| NBA105020 | Length 20 mm | In distribution |
| NBG045050 | Length 50 mm | In distribution |
| NBA070110 | Length 110 mm | In distribution |
| NZA024075 | Length 60 mm | In distribution |
| NBH075040 | Length 40 mm | In distribution |
| NBG075120 | Length 120 mm | In distribution |
| NBG045045 | Length 45 mm | In distribution |
| NBG050030 | Length 30 mm | In distribution |
| NBG050020 | Length 20 mm | In distribution |
| NBA090035 | Length 35 mm | In distribution |
| NBH080050 | Length 50 mm | In distribution |
| NBG060060 | Length 55 mm | In distribution |
| NBH075120 | Length 120 mm | In distribution |
| NBG055025 | Length 25 mm | In distribution |
| NZA024065 | Length 60 mm | In distribution |
| NBA075040 | Length 40 mm | In distribution |
| NBG080075 | Length 75 mm | In distribution |
| NBA085120 | Length 120 mm | In distribution |
| NBH075105 | Length 105 mm | In distribution |
| NBA080020 | Length 20 mm | In distribution |
| NBA080120 | Length 120 mm | In distribution |
| NBA105105 | Length 105 mm | In distribution |
| NBA080055 | Length 55 mm | In distribution |
| NBA090065 | Length 65 mm | In distribution |
| NBH075060 | Length 60 mm | In distribution |
| NBA085040 | Length 40 mm | In distribution |
| NBA075060 | Length 60 mm | In distribution |
| NBH085045 | Length 45 mm | In distribution |
| NBA095060 | Length 60 mm | In distribution |
| NBH080070 | Length 70 mm | In distribution |
| NBA105050 | Length 50 mm | In distribution |
| NBA105035 | Length 35 mm | In distribution |
| NBA085065 | Length 65 mm | In distribution |
| NBA105090 | Length 90 mm | In distribution |
| NBA085080 | Length 80 mm | In distribution |
| NBA095115 | Length 115 mm | In distribution |
| NBH070060 | Length 60 mm | In distribution |
| NBA080080 | Length 80 mm | In distribution |
| NBA085100 | Length 100 mm | In distribution |
| NBH075050 | Length 50 mm | In distribution |
| NBA100105 | Length 105 mm | In distribution |
| NBA095095 | Length 95 mm | In distribution |
| NBA090070 | Length 70 mm | In distribution |
| NBA095050 | Length 50 mm | In distribution |
| NBA080030 | Length 25 mm | In distribution |
| NBA100090 | Length 90 mm | In distribution |
| NBA095065 | Length 65 mm | In distribution |
| NBA085110 | Length 110 mm | In distribution |
| NBG050035 | Length 35 mm | In distribution |
| NBH080120 | Length 120 mm | In distribution |
| NBH075070 | Length 70 mm | In distribution |
| NBA105065 | Length 60 mm | In distribution |
| NBG040035 | Length 35 mm | In distribution |
| NBA105095 | Length 95 mm | In distribution |
| NBH070045 | Length 55 mm | In distribution |
| NBA080050 | Length 50 mm | In distribution |
| NBA100075 | Length 75 mm | In distribution |
| NZA024075 | In distribution | |
| NBG075045 | Length 45 mm | In distribution |
| NBA075120 | Length 120 mm | In distribution |
| NBG060050 | Length 50 mm | In distribution |
| NBA090095 | Length 95 mm | In distribution |
| NBA080025 | Length 25 mm | In distribution |
| NBA100050 | Length 50 mm | In distribution |
| NBA100035 | Length 35 mm | In distribution |
| NBA085060 | Length 60 mm | In distribution |
| NBA105085 | Length 85 mm | In distribution |
| NZA024080 | In distribution | |
| NBH080095 | Length 95 mm | In distribution |
| NBG060035 | Length 35 mm | In distribution |
| NBA075085 | Length 85 mm | In distribution |
| NBA075080 | Length 80 mm | In distribution |
| NBG075095 | Length 95 mm | In distribution |
| NBA095055 | Length 55 mm | In distribution |
| NBA080105 | Length 105 mm | In distribution |
| NBA095040 | Length 40 mm | In distribution |
| NBA080100 | Length 100 mm | In distribution |
| NBG075100 | Length 100 mm | In distribution |
| NBA080065 | Length 65 mm | In distribution |
| NBG040040 | Length 40 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
| Orthopedic Stereotaxic Instrument | Mako Surgical Corp. | 124 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240160 | 2024-10-17 |
| K182982 | 2019-01-04 |
| K172166 | 2018-04-27 |
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.