PMT Corporation – Stereotactic
LEKSELL sEEG KIT: 2103-34 (QTY 2), 2103-52, 2103-92, 2103-60, 2103-68, 2103-69, 2103-87, 2103-88, 2103-93, 2103-97, FOR 2.1MM DRILL
5manufacturers in China registered for this device type
255catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Sinovation (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | PMT Corp., United States |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K831329 |
| Record published | 2016-11-16 |
| Record revised | 2026-06-23 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Hydrogen Peroxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Sizes | Length 20 to 240 mm; outer diameter 1.2 to 4 mm; length 35 to 254 cm; length 1 in; lumen/inner diameter 2.7 to 3.2 mm; outer diameter 0.125 in; lumen/inner diameter 0.069 in |
| Distribution end date | 2025-03-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2103-28-30 | Length 30 mm | In distribution | |
| 2103-89 | In distribution | ||
| 2103-20 | In distribution | ||
| 2103-161 | In distribution | ||
| 2103-71 | In distribution | ||
| 2103-23-35 | Length 35 mm | In distribution | |
| 2103-144 | In distribution | ||
| 2103-19-25 | Length 25 mm | In distribution | |
| 2103-132 | In distribution | ||
| 2103-13 | In distribution | ||
| 2103-174 | In distribution | ||
| 2103-222 | In distribution | ||
| 2103-27-40 | Length 40 mm | In distribution | |
| 2103-108 | In distribution | ||
| 2103-15-25-NS | In distribution | ||
| 2103-154 | In distribution | ||
| 2103-26 | In distribution | ||
| 2103-37 | In distribution | ||
| 2103-215 | In distribution | ||
| 2103-129 | In distribution | ||
| 2103-27-25-NS | Length 25 mm | In distribution | |
| 2103-53 | In distribution | ||
| 2103-87 | In distribution | ||
| 2103-15-35 | Length 35 mm | In distribution | |
| 2103-183 | In distribution | ||
| 2103-30-25 | Length 25 mm | In distribution | |
| 2103-79 | Length 60 mm | In distribution | |
| 2103-46 | In distribution | ||
| 2103-122 | In distribution | ||
| 2103-96 | In distribution | ||
| 2103-01 | In distribution | ||
| 2103-22 | In distribution | ||
| 2103-83 | In distribution | ||
| 2103-234 | In distribution | ||
| 2103-168 | In distribution | ||
| 2103-145 | Length 45 mm | In distribution | |
| 2103-38 | In distribution | ||
| 2103-82 | In distribution | ||
| 2103-33 | In distribution | ||
| 2103-28-40 | Length 40 mm | In distribution | |
| 2103-57 | In distribution | ||
| 2103-190-NS | In distribution | ||
| 2103-169 | In distribution | ||
| 2103-24 | In distribution | ||
| 2103-88 | In distribution | ||
| 2103-07 | In distribution | ||
| 2103-229 | In distribution | ||
| 2103-239 | In distribution | ||
| 2103-152-35-NS | Length 35 mm | In distribution | |
| 2103-36 | In distribution | ||
| 2103-123 | In distribution | ||
| 2103-152-30 | In distribution | ||
| 2103-166 | In distribution | ||
| 2103-134 | In distribution | ||
| 2103-178 | In distribution | ||
| 2103-112 | Length 120 mm | In distribution | |
| 2103-144 | In distribution | ||
| 2103-25 | In distribution | ||
| 2103-29-35-NS | Length 35 mm | In distribution | |
| 2103-225 | In distribution | ||
| 2103-141 | 5 | In distribution | |
| 2103-48 | In distribution | ||
| 2103-100 | In distribution | ||
| 2103-153 | In distribution | ||
| 2103-184 | In distribution | ||
| 2103-106 | In distribution | ||
| 2103-51 | In distribution | ||
| 2103-159 | Hole Diameter 4.75 Millimeter | In distribution | |
| 2103-15-30-NS | In distribution | ||
| 2103-192 | In distribution | ||
| 2103-35 | In distribution | ||
| 2103-10 | In distribution | ||
| 2103-39 | Length 190 mm | In distribution | |
| 2103-213 | In distribution | ||
| 2103-29-35 | Length 35 mm | In distribution | |
| 2103-34 | In distribution | ||
| 2103-15-20-NS | In distribution | ||
| 2103-27-35 | Length 35 mm | In distribution | |
| 2103-257 | In distribution | ||
| 2103-97 | In distribution | ||
| 2103-44 | In distribution | ||
| 2103-70 | Length 70 mm | In distribution | |
| 2103-110 | In distribution | ||
| 2103-68 | In distribution | ||
| 2103-104 | In distribution | ||
| 2103-65 | Length 1 in | In distribution | |
| 2103-28-25 | Length 25 mm | In distribution | |
| 2103-149 | In distribution | ||
| 2103-237 | In distribution | ||
| 2103-204 | In distribution | ||
| 2103-56 | Outer Diameter 4 mm | In distribution | |
| 2103-244 | In distribution | ||
| 2103-78 | In distribution | ||
| 2103-156 | Length 175 mm | In distribution | |
| 2103-188 | In distribution | ||
| 2103-29-20-NS | In distribution | ||
| 2103-29-30 | Length 30 mm | In distribution | |
| 2103-199 | In distribution | ||
| 2103-133 | In distribution | ||
| 2103-165 | In distribution | ||
| 2103-139 | In distribution | ||
| 2103-23-25 | Length 25 mm | In distribution | |
| 2103-135 | In distribution | ||
| 2103-118 | Length 254 cm | In distribution | |
| 2103-50 | In distribution | ||
| 2103-179 | In distribution | ||
| 2103-187 | In distribution | ||
| 2103-127 | In distribution | ||
| 2103-28-25-NS | In distribution | ||
| 2103-67 | In distribution | ||
| 2103-15-25 | Length 25 mm | In distribution | |
| 2103-95 | In distribution | ||
| 2103-194 | In distribution | ||
| 2103-14 | In distribution | ||
| 2103-85 | Length 100 mm | In distribution | |
| 2103-12 | In distribution | ||
| 2103-76 | In distribution | ||
| 2103-101 | In distribution | ||
| 2103-03 | In distribution | ||
| 2103-64 | In distribution | ||
| 2103-140 | In distribution | ||
| 2103-152-20 | In distribution | ||
| 2103-233 | In distribution | ||
| 2103-176 | In distribution | ||
| 2103-197 | In distribution | ||
| 2103-81 | In distribution | ||
| 2103-105 | In distribution | ||
| 2103-42 | In distribution | ||
| 2103-60 | In distribution | ||
| 2103-19-40 | In distribution | ||
| 2103-216 | In distribution | ||
| 2103-241 | In distribution | ||
| 2103-90 | In distribution | ||
| 2103-45 | In distribution | ||
| 2103-202 | In distribution | ||
| 2103-04 | In distribution | ||
| 2103-136 | In distribution | ||
| 2103-41 | In distribution | ||
| 2103-209 | In distribution | ||
| 2103-115 | In distribution | ||
| 2103-74 | In distribution | ||
| 2103-05 | In distribution | ||
| 2103-196 | In distribution | ||
| 2103-52 | In distribution | ||
| 2103-151-35-NS | Length 35 mm | In distribution | |
| 2103-247 | In distribution | ||
| 2103-142 | In distribution | ||
| 2103-147 | Length 85 mm | In distribution | |
| 2103-15-30 | Length 30 mm | In distribution | |
| 2103-08 | In distribution | ||
| 2103-72 | In distribution | ||
| 2103-138 | In distribution | ||
| 2103-195 | In distribution | ||
| 2103-120 | In distribution | ||
| 2103-191 | In distribution | ||
| 2103-167 | In distribution | ||
| 2103-103 | In distribution | ||
| 2103-94 | In distribution | ||
| 2103-61 | In distribution | ||
| 2103-148 | In distribution | ||
| 2103-31 | In distribution | ||
| 2103-172 | In distribution | ||
| 2103-43 | In distribution | ||
| 2103-80 | Outer Diameter 4 mm | In distribution | |
| 2103-02 | In distribution | ||
| 2103-125 | In distribution | ||
| 2103-09 | In distribution | ||
| 2103-152-35 | Length 35 mm | In distribution | |
| 2103-11 | In distribution | ||
| 2103-69 | In distribution | ||
| 2103-27-25 | Length 25 mm | In distribution | |
| 2103-15-20 | Length 20 mm | In distribution | |
| 2103-190 | In distribution | ||
| 2103-91 | Outer Diameter 1.2 mm | In distribution | |
| 2103-15-35-NS | In distribution | ||
| 2103-73 | In distribution | ||
| 2103-200 | In distribution | ||
| 2103-170 | In distribution | ||
| 2103-114 | In distribution | ||
| 2103-109 | In distribution | ||
| 2103-137 | In distribution | ||
| 2103-17 | In distribution | ||
| 2103-16 | In distribution | ||
| 2103-111 | In distribution | ||
| 2103-32 | In distribution | ||
| 2103-19-35 | Length 35 mm | In distribution | |
| 2103-30-30 | Length 30 mm | In distribution | |
| 2103-40 | Length 240 mm | In distribution | |
| 2103-152-25 | In distribution | ||
| 2103-19-30 | Length 30 mm | In distribution | |
| 2103-102 | In distribution | ||
| 2103-151-25 | In distribution | ||
| 2103-28-35 | Length 35 mm | In distribution | |
| 2103-177 | In distribution | ||
| 2103-193 | In distribution | ||
| 2103-173 | In distribution | ||
| 2103-23-30 | Length 30 mm | In distribution | |
| 2103-124 | In distribution | ||
| 2103-223 | In distribution | ||
| 2103-49 | In distribution | ||
| 2103-131 | In distribution | ||
| 2103-66 | In distribution | ||
| 2103-130 | In distribution | ||
| 2103-98 | In distribution | ||
| 2103-58 | In distribution | ||
| 2103-217 | In distribution | ||
| 2103-77 | In distribution | ||
| 2103-250 | In distribution | ||
| 2103-151-35 | Length 35 mm | In distribution | |
| 2103-29-25 | Length 25 mm | In distribution | |
| 2103-216-NS | In distribution | ||
| 2103-205 | In distribution | ||
| 2103-242 | In distribution | ||
| 2103-55 | In distribution | ||
| 2103-21-NS | In distribution | ||
| 2103-119 | Outer Diameter 1.2 mm | In distribution | |
| 2103-164 | In distribution | ||
| 2103-23-40 | Length 40 mm | In distribution | |
| 2103-157 | In distribution | ||
| 2103-236 | In distribution | ||
| 2103-93 | Length 1 in | In distribution | |
| 2103-47 | In distribution | ||
| 2103-62 | In distribution | ||
| 2103-28-30-NS | In distribution | ||
| 2103-18 | In distribution | ||
| 2103-15-40 | In distribution | ||
| 2103-235 | In distribution | ||
| 2103-175 | In distribution | ||
| 2103-121 | In distribution | ||
| 2103-86 | Length 75 mm | In distribution | |
| 2103-27-30 | Length 30 mm | In distribution | |
| 2103-189 | In distribution | ||
| 2103-107 | In distribution | ||
| 2103-29-25-NS | In distribution | ||
| 2103-146 | Length 65 mm | In distribution | |
| 2103-92 | In distribution | ||
| 2103-178-NS | In distribution | ||
| 2103-117 | Outer Diameter 2.4 mm | In distribution | |
| 2103-171 | In distribution | ||
| 2103-75 | Length 85 mm | In distribution | |
| 2103-143 | In distribution | ||
| 2103-59 | In distribution | ||
| 2103-238 | In distribution | ||
| 2103-29-20 | Length 20 mm | In distribution | |
| 2103-152-40 | In distribution | ||
| 2103-06 | In distribution | ||
| 2103-54 | In distribution | ||
| 2103-63 | In distribution | ||
| 2103-116 | Length 35 cm | In distribution | |
| 2103-21 | In distribution |
Showing 250 of 255 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neurological Stereotaxic Instrument | Medtronic Navigation, Inc. | 844 |
| Leksell Stereotactic System | Elekta Instrument AB | 199 |
| Neurological Stereotaxic Instrument | Inomed Medizintechnik Gmbh | 146 |
| Neurological Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 125 |
| Geniant Cranial | KOH Young Technology Inc. | 113 |
| CRW® | Integra Lifesciences Corporation | 107 |
| Leksell Stereotactic System | Elekta Solutions AB | 93 |
| microTargeting™ Insertion Tube with Stylet | FHC, Inc. | 60 |
| Leksell Stereotactic System Neurosurgical Instruments | Elekta Instrument AB | 58 |
| Leksell Vantage Stereotactic System | Elekta Instrument AB | 53 |
| Stealth Autoguide™ System | Medtronic Navigation, Inc. | 50 |
| microTargeting™ Insertion Tube | FHC, Inc. | 48 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
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.