Klockner
Klockner Sniper JSI Guided Surgery KIT [WT]
5manufacturers in China registered for this device type
50catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (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 |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Lianyungang Anson Non-woven Product Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 13 |
| Medipack Medical Packaging MFG. Co. | Dongguan | Guangdong | Contract manufacturer | 5 |
| AR Medicom Inc., (Asia), Ltd. | Hongkong | Hong Kong | Exporter | 5 |
| Wipak Packaging (Changshu) Co., Ltd. | Changshu | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Soadco, S.L., AD |
|---|---|
| FDA product code | KCT |
| Device type | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6850 |
| Establishment | Manufacturer |
| 510(k) | K173642 |
| Record published | 2025-02-14 |
| Record revised | 2025-02-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KIT 10 00 04 | In distribution | |
| 10 00 04 | In distribution | |
| KIT 10 00 04 | In distribution | |
| KIT WT SNIPER | In distribution | |
| KIT 10 00 02 | In distribution | |
| KIT ESSENTIAL | In distribution | |
| KIT WT ESSENTIAL | In distribution | |
| KIT VEGA | In distribution | |
| KIT EXTERNA | In distribution | |
| KIT 10 00 06 | In distribution | |
| 10 00 06 | In distribution | |
| KIT 10 00 02 | In distribution | |
| 10 00 02 | In distribution | |
| KIT ESSENTIAL | In distribution | |
| KIT EXTERNA | In distribution | |
| 10 00 07 | In distribution | |
| KIT INTERNA | In distribution | |
| KIT MEDGUIDE | In distribution | |
| KIT WT SNIPER | In distribution | |
| 10 00 03 | In distribution | |
| KIT EXTERNA | In distribution | |
| KIT 20 06 00 ESS | In distribution | |
| KIT 10 00 06 | In distribution | |
| KIT VEGA | In distribution | |
| KIT WT SNIPER JSI | In distribution | |
| 10 00 08 | In distribution | |
| KIT WT SNIPER JSI | In distribution | |
| KIT WT VEGA | In distribution | |
| KIT WT ESSENTIAL | In distribution | |
| 10 06 21 P | In distribution | |
| KIT ESSENTIAL | In distribution | |
| KIT INTERNA | In distribution | |
| KIT WT INTERNA | In distribution | |
| KIT MEDGUIDE | In distribution | |
| KIT MEDGUIDE | In distribution | |
| KIT INTERNA | In distribution | |
| 20 06 00 | In distribution | |
| 10 06 22 P | In distribution | |
| 10 00 04 | In distribution | |
| KIT 10 00 03 | In distribution | |
| 10 00 06 | In distribution | |
| 10 00 08 | In distribution | |
| KIT WT INTERNA | In distribution | |
| KIT 10 00 03 | In distribution | |
| 10 06 22 P | In distribution | |
| KIT 10 00 04 | In distribution | |
| KIT WT VEGA | In distribution | |
| KIT VEGA | In distribution | |
| 10 00 03 | In distribution | |
| KIT ESSENTIAL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrusafe | Summit Medical LLC | 6,357 |
| V. Mueller | Steris Corporation | 1,080 |
| Ermis | Ermis MedTech | 597 |
| Bahadir USA | Bahadir USA LLC | 561 |
| Avalign | Avalign Technologies, Inc. | 447 |
| Sklar® | Sklar Corporation | 363 |
| HNM Medical | HNM Stainless, LLC. | 337 |
| Surgical Instrument | SIN Sistema DE Implante Nacional S.A | 295 |
| ReLine | Nuvasive, Inc. | 290 |
| Case Medical | Case Medical, Inc. | 289 |
| Millennium | Avalign Technologies, Inc. | 268 |
| V. Mueller | Carefusion 2200, Inc. | 174 |
Showing 12 of 599. All products under Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243128 | 2024-12-18 |
| K173642 | 2018-10-02 |
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.