Kleiner KG2 System
Cover Plate Grip Remover/Repositioner
14manufacturers in China registered for this device type
220catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (6), Shandong (2), Shanghai (2). 7 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Jiangsu Ideal Medical Science & Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Zhisu Health Tech Jiaxing Co., Ltd. | Tongxiang | Zhejiang | Contract manufacturer | 4 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Double Medical Technology Inc. | Xiamen | Fujian | Contract manufacturer | 14 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Showing 12 of 14. All 14 manufacturers in China registered for Intervertebral Fusion Device With Bone Graft, Lumbar
Record
| Listed by | Baat Medical Products B.V., Netherlands |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Record published | 2022-12-14 |
| Record revised | 2025-07-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KG2 Instruments | In distribution | |
| Trial, 11x36x11mm Parallel | In distribution | |
| KG2 Static Lordotic 9x24x16x6° | In distribution | |
| KG2 Static Parallel 11x28x16x0° | In distribution | |
| KG2 Static Lordotic 11x28x10x6° | In distribution | |
| KG2 Static Lordotic 11x36x12x6° | In distribution | |
| Trial, 9x24x16mm Parallel | In distribution | |
| KG2 Static Parallel 11x28x11x0° | In distribution | |
| KG2 Static Lordotic 11x28x15x6° | In distribution | |
| Slap Hammer | In distribution | |
| Trial, 9x24x14mm Parallel | In distribution | |
| KG2 Static Parallel 11x32x10x0° | In distribution | |
| KG2 Static Parallel 11x28x09x0° | In distribution | |
| Trial, 11x36x15mm Parallel | In distribution | |
| Disc Prep Shavers and Distractors | In distribution | |
| Trial, 11x36x14mm Parallel | In distribution | |
| Distractor, 12mm | In distribution | |
| KG2 Static Parallel 11x32x16x0° | In distribution | |
| KG2 Static Parallel 9x24x14x0° | In distribution | |
| KG2 Static Lordotic 11x32x14x6° | In distribution | |
| KG2 Static Parallel 11x36x08x0° | In distribution | |
| KG2 Static Lordotic 9x24x10x6° | In distribution | |
| KG2 Static Lordotic 11x32x11x6° | In distribution | |
| Shavers and Distractors | In distribution | |
| KG2 Static Parallel 9x24x11x0° | In distribution | |
| KG2 Static Parallel 11x36x16x0° | In distribution | |
| KG2 Static Parallel 11x28x15x0° | In distribution | |
| KG2 Static Lordotic 11x36x10x6° | In distribution | |
| KG2 Static Lordotic 11x28x11x6° | In distribution | |
| KG2 Static Lordotic 9x24x09x6° | In distribution | |
| Shaver, 12mm | In distribution | |
| KG2 Static Lordotic 11x36x11x6° | In distribution | |
| Trial, 11x36x16mm Parallel | In distribution | |
| Shaver, 13mm | In distribution | |
| KG2 Static Lordotic 9x24x14x6° | In distribution | |
| KG2 Static Parallel 11x28x15x0° | In distribution | |
| KG2 Static Lordotic 9x24x12x6° | In distribution | |
| KG2 Static Parallel 9x24x12x0° | In distribution | |
| KG2 Static Parallel 9x24x16x0° | In distribution | |
| KG2 Static Parallel 9x24x16x0° | In distribution | |
| Inserter Slap Hammer Adaptor | In distribution | |
| Tray 1 | In distribution | |
| Trial, 11x36x10mm Parallel | In distribution | |
| KG2 Static Parallel 11x32x07x0° | In distribution | |
| Trial, 11x36x12mm Lordotic | In distribution | |
| KG2 Static Lordotic 11x32x14x6° | In distribution | |
| KG2 Static Lordotic 9x24x15x6° | In distribution | |
| KG2 Static Parallel 11x32x07x0° | In distribution | |
| Distractor, 7mm | In distribution | |
| Disc Prep Base | In distribution | |
| KG2 Static Lordotic 9x24x13x6° | In distribution | |
| KG2 Static Parallel 11x28x07x0° | In distribution | |
| KG2 Static Parallel 11x32x10x0° | In distribution | |
| KG2 Static Parallel 11x36x11x0° | In distribution | |
| KG2 Static Parallel 11x32x09x0° | In distribution | |
| KG2 Static Parallel 9x24x13x0° | In distribution | |
| Side Grip Remover/Repositoiner, 9×7 | In distribution | |
| KG2 Static Lordotic 11x28x13x6° | In distribution | |
| KG2 Static Parallel 11x28x07x0° | In distribution | |
| Sterilization case 2 | In distribution | |
| KG2 Static Parallel 9x24x10x0° | In distribution | |
| KG2 Trials | In distribution | |
| Shaver, 15mm | In distribution | |
| KG2 Static Parallel 9x24x07x0° | In distribution | |
| KG2 Static Lordotic 11x32x16x6° | In distribution | |
| KG2 Static Parallel 11x32x08x0° | In distribution | |
| KG2 Static Parallel 9x24x09x0° | In distribution | |
| KG2 Static Lordotic 11x28x15x6° | In distribution | |
| KG2 Static Lordotic 11x36x10x6° | In distribution | |
| Distractor, 15mm | In distribution | |
| KG2 Static Lordotic 11x36x15x6° | In distribution | |
| Trial, 11x36x15mm Lordotic | In distribution | |
| KG2 Static Lordotic 11x36x13x6° | In distribution | |
| Side Grip Remover/Repositoiner, 11×8 | In distribution | |
| T-handle, Hudson Connect | In distribution | |
| KG2 Static Parallel 11x28x13x0° | In distribution | |
| KG2 Static Lordotic 11x28x14x6° | In distribution | |
| KG2 Static Lordotic 11x36x15x6° | In distribution | |
| KG2 Static Parallel 11x32x11x0° | In distribution | |
| Trial, 11x36x7mm Parallel | In distribution | |
| KG2 Static Lordotic 11x36x11x6° | In distribution | |
| KG2 Static Lordotic 11x28x09x6° | In distribution | |
| KG2 Static Parallel 11x36x14x0° | In distribution | |
| KG2 Static Parallel 11x32x08x0° | In distribution | |
| KG2 Static Parallel 11x36x16x0° | In distribution | |
| KG2 Static Lordotic 11x32x13x6° | In distribution | |
| KG2 Static Parallel 11x36x13x0° | In distribution | |
| KG2 Static Parallel 11x36x11x0° | In distribution | |
| KG2 Static Lordotic 11x28x16x6° | In distribution | |
| KG2 Static Parallel 11x32x11x0° | In distribution | |
| Trial, 9x24x11mm Parallel | In distribution | |
| KG2 Static Lordotic 11x28x16x6° | In distribution | |
| Hook Remover | In distribution | |
| Shaver, 10mm | In distribution | |
| KG2 Static Parallel 11x32x12x0° | In distribution | |
| KG2 Static Parallel 11x32x15x0° | In distribution | |
| KG2 Static Parallel 11x28x10x0° | In distribution | |
| KG2 Static Parallel 11x28x08x0° | In distribution | |
| KG2 Static Parallel 11x28x11x0° | In distribution | |
| Distractor, 13mm | In distribution | |
| Trial, 9x24x12mm Lordotic | In distribution | |
| Trial, 11x36x11mm Lordotic | In distribution | |
| KG2 Static Parallel 11x28x08x0° | In distribution | |
| Trial, 9x24x13mm Parallel | In distribution | |
| KG2 Static Parallel 11x32x13x0° | In distribution | |
| KG2 Static Parallel 11x36x13x0° | In distribution | |
| KG2 Static Parallel 11x36x15x0° | In distribution | |
| Shaver, 16mm | In distribution | |
| KG2 Static Parallel 9x24x13x0° | In distribution | |
| KG2 Static Lordotic 11x32x12x6° | In distribution | |
| Trial, 11x36x9mm Parallel | In distribution | |
| KG2 Static Lordotic 11x36x12x6° | In distribution | |
| KG2 Static Parallel 9x24x09x0° | In distribution | |
| Trial, 11x36x13mm Lordotic | In distribution | |
| KG2 Static Parallel 11x32x13x0° | In distribution | |
| Trial, 11x36x12mm Parallel | In distribution | |
| KG2 Static Lordotic 11x28x11x6° | In distribution | |
| KG2 Static Parallel 9x24x15x0° | In distribution | |
| KG2 Static Parallel 9x24x07x0° | In distribution | |
| Trial, 11x36x8mm Parallel | In distribution | |
| KG2 Static Lordotic 11x28x14x6° | In distribution | |
| KG2 Static Lordotic 9x24x10x6° | In distribution | |
| Distractor, 9mm | In distribution | |
| KG2 Static Lordotic 9x24x12x6° | In distribution | |
| Trial, 11x36x10mm Lordotic | In distribution | |
| Distractor, 10mm | In distribution | |
| KG2 Static Parallel 11x28x14x0° | In distribution | |
| Shaver, 7mm | In distribution | |
| KG2 Static Lordotic 9x24x16x6° | In distribution | |
| KG2 Static Lordotic 9x24x15x6° | In distribution | |
| Distractor, 16mm | In distribution | |
| KG2 Static Parallel 11x36x08x0° | In distribution | |
| Shaver, 14mm | In distribution | |
| KG2 Static Parallel 9x24x08x0° | In distribution | |
| KG2 Static Parallel 11x36x09x0° | In distribution | |
| Lid 2 | In distribution | |
| KG2 Static Lordotic 11x36x14x6° | In distribution | |
| KG2 Static Lordotic 11x32x10x6° | In distribution | |
| KG2 Static Parallel 11x28x09x0° | In distribution | |
| KG2 Static Parallel 9x24x11x0° | In distribution | |
| KG2 Static Lordotic 11x32x13x6° | In distribution | |
| KG2 Static Parallel 11x28x13x0° | In distribution | |
| KG2 Static Parallel 11x36x07x0° | In distribution | |
| Distractor, 8mm | In distribution | |
| KG2 Static Parallel 11x36x10x0° | In distribution | |
| KG2 Static Parallel 11x36x07x0° | In distribution | |
| KG2 Static Lordotic 11x32x11x6° | In distribution | |
| KG2 Static Lordotic 11x28x09x6° | In distribution | |
| KG2 Static Parallel 11x32x14x0° | In distribution | |
| Shaver, 8mm | In distribution | |
| KG2 Static Parallel 11x28x12x0° | In distribution | |
| KG2 Static Parallel 11x28x10x0° | In distribution | |
| Distractor, 11mm | In distribution | |
| Tray 2 | In distribution | |
| KG2 Static Parallel 9x24x15x0° | In distribution | |
| KG2 Static Parallel 11x32x16x0° | In distribution | |
| Shaver, 9mm | In distribution | |
| KG2 Static Parallel 11x36x14x0° | In distribution | |
| Trial, 9x24x12mm Parallel | In distribution | |
| Trial, 9x24x13mm Lordotic | In distribution | |
| Trial, 9x24x14mm Lordotic | In distribution | |
| KG2 Static Lordotic 11x28x12x6° | In distribution | |
| Trial, 9x24x10mm Lordotic | In distribution | |
| Cover Plate Grip Remover/Repositioner | In distribution | |
| KG2 Static Lordotic 11x36x13x6° | In distribution | |
| KG2 Static Lordotic 11x32x10x6° | In distribution | |
| KG2 Static Parallel 11x32x09x0° | In distribution | |
| Trial, 9x24x9mm Parallel | In distribution | |
| Trial, 11x36x13mm Parallel | In distribution | |
| KG2 Static Parallel 11x28x12x0° | In distribution | |
| Trial, 9x24x15mm Lordotic | In distribution | |
| Trial, 9x24x10mm Parallel | In distribution | |
| KG2 Static Parallel 11x32x15x0° | In distribution | |
| Side Grip Remover/Repositioner, Lock | In distribution | |
| KG2 Static Parallel 11x36x12x0° | In distribution | |
| KG2 Static Lordotic 11x36x16x6° | In distribution | |
| KG2 Static Lordotic 11x28x10x6° | In distribution | |
| Lid 1 | In distribution | |
| Base 2 | In distribution | |
| Trial, 11x36x16mm Lordotic | In distribution | |
| Trial, 9x24x11mm Lordotic | In distribution | |
| KG2 Static Parallel 9x24x10x0° | In distribution | |
| Shaver, 11mm | In distribution | |
| KG2 Static Parallel 11x28x14x0° | In distribution | |
| Trial, 9x24x9mm Lordotic | In distribution | |
| KG2 Static Lordotic 9x24x14x6° | In distribution | |
| Distractor, 14mm | In distribution | |
| KG2 Static Parallel 9x24x08x0° | In distribution | |
| Trial, 9x24x7mm Parallel | In distribution | |
| Trial, 9x24x16mm Lordotic | In distribution | |
| KG2 Static Lordotic 11x32x15x6° | In distribution | |
| Trial, 9x24x8mm Parallel | In distribution | |
| KG2 Static Lordotic 9x24x11x6° | In distribution | |
| KG2 Static Parallel 11x32x14x0° | In distribution | |
| Trial, 11x36x9mm Lordotic | In distribution | |
| Base 1 | In distribution | |
| KG2 Static Lordotic 9x24x11x6° | In distribution | |
| KG2 Static Lordotic 9x24x09x6° | In distribution | |
| KG2 Static Parallel 11x36x10x0° | In distribution | |
| Distractor, 6mm | In distribution | |
| KG2 Static Lordotic 11x28x13x6° | In distribution | |
| KG2 Static Lordotic 11x32x12x6° | In distribution | |
| KG2 Static Lordotic 11x28x12x6° | In distribution | |
| KG2 Static Interbody: Auxillary Instruments | In distribution | |
| KG2 Static Parallel 11x36x12x0° | In distribution | |
| KG2 Static Lordotic 11x32x16x6° | In distribution | |
| KG2 Static Parallel 11x36x15x0° | In distribution | |
| KG2 Static Parallel 9x24x12x0° | In distribution | |
| KG2 Static Parallel 11x32x12x0° | In distribution | |
| KG2 Static Parallel 11x36x09x0° | In distribution | |
| KG2 Static Lordotic 11x36x16x6° | In distribution | |
| KG2 Static Lordotic 11x32x15x6° | In distribution | |
| KG2 Static Lordotic 9x24x13x6° | In distribution | |
| Shaver, 6mm | In distribution | |
| KG2 Static Parallel 11x28x16x0° | In distribution | |
| KG2 Static Parallel 9x24x14x0° | In distribution | |
| Trial, 11x36x14mm Lordotic | In distribution | |
| KG2 Static Lordotic 11x36x14x6° | In distribution | |
| Trial, 9x24x15mm Parallel | In distribution | |
| Sterilization case 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Peridot Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 10,850 |
| Yellowstone | Summit Spine | 6,654 |
| CoRoent | Nuvasive, Inc. | 5,690 |
| Zavation | Zavation | 2,554 |
| Anyplus II Spinal Fixation System | GS Medical Co., Ltd. | 2,533 |
| Talos® IBF | Meditech Spine, LLC | 2,163 |
| Peridot-PT Intervertebral body fusion system | Gbs Commonwealth Co., Ltd. | 1,956 |
| TirboLOX-L Lumbar Ibfd | Captiva Spine, Inc. | 1,926 |
| Endoskeleton® TL | Titan Spine, LLC | 1,896 |
| Evos Lumbar Interbody System | Cutting Edge Spine | 1,871 |
| Epiphany | Pantheon Spinal LLC | 1,507 |
| LnK Lumbar Interbody Fusion Cage System | L&K Biomed Co., Ltd. | 1,506 |
Showing 12 of 1,958. All products under Intervertebral Fusion Device With Bone Graft, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211474 | 2021-09-14 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P000028 | 2004-06-18 | AFFINITY ANTERIOR CERVICAL CAGE SYSTEM | Medtronic Sofamor Danek USA, Inc. |
| P970015 | 2003-09-10 | LT-CAGE PEEK LUMBAR TAPERED FUSION DEVICE | Sofamor Danek |
| P980048 | 2001-04-20 | BAK/CERVICAL (BAK/C) INTERBODY FUSION SYSTEM | Sulzer Spine-Tech |
| P950019 | 1999-03-19 | RAY THREADED FUSION CAGE (TFC) DEVICE WITH INSTRUMENTATION | Stryker Spine |
| P950002 | 1997-06-30 | BAK INTERBODY FUSION SYSTEM | Zimmer Spine, Inc. |
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.