Shark™ Lumbar Spacer System
PLI,SPACER,SHARK,Ti,9,28X14,4 DEG
14manufacturers in China registered for this device type
135catalogue numbers in this listing
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 | Choice Spine, LP |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K140142 |
| Record published | 2016-03-10 |
| Record revised | 2022-08-30 (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 | Height 7 to 18 mm; length 20 to 32 mm; width 9 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PP22-22154 | In distribution | |
| PP22-22080 | Height 8 mm | In distribution |
| PP20-28160 | Height 16 mm | In distribution |
| PP20-25130 | Length 25 mm | In distribution |
| PP20-32120 | Length 32 mm | In distribution |
| PP22-25120 | Length 25 mm | In distribution |
| PP20-25090 | Height 9 mm | In distribution |
| PP22-22134 | In distribution | |
| PP20-28154 | Length 28 mm | In distribution |
| PP22-28090 | Height 9 mm | In distribution |
| PP20-28170 | Height 17 mm | In distribution |
| PP10-20144 | Length 20 mm | In distribution |
| PP22-28170 | Width 9 mm | In distribution |
| PP22-25140 | Height 14 mm | In distribution |
| PP20-28130 | Height 13 mm | In distribution |
| PP20-28114 | Length 28 mm | In distribution |
| PP20-22090 | Height 9 mm | In distribution |
| PP20-28094 | Height 9 mm | In distribution |
| PP10-20164 | Height 16 mm | In distribution |
| PP20-25150 | Height 15 mm | In distribution |
| PP20-32100 | Height 10 mm | In distribution |
| PP22-25124 | In distribution | |
| PP22-28154 | In distribution | |
| PP22-28160 | Width 9 mm | In distribution |
| PP20-32130 | Length 32 mm | In distribution |
| PP22-28174 | In distribution | |
| PP20-25180 | Height 18 mm | In distribution |
| PP20-28174 | Height 17 mm | In distribution |
| PP20-25140 | Height 14 mm | In distribution |
| PT22-25074 | Length 25 mm | In distribution |
| PP10-20124 | Height 12 mm | In distribution |
| PT22-28144 | Height 14 mm | In distribution |
| PP20-28144 | Length 28 mm | In distribution |
| PT22-25184 | Height 18 mm | In distribution |
| PP22-28144 | In distribution | |
| PP22-22170 | Length 22 mm | In distribution |
| PP22-25160 | Height 16 mm | In distribution |
| PP20-22160 | Length 22 mm | In distribution |
| PP20-25070 | Height 7 mm | In distribution |
| PP22-28114 | In distribution | |
| PP22-22074 | In distribution | |
| PP20-32150 | Height 15 mm | In distribution |
| PP22-25134 | In distribution | |
| PP22-22174 | In distribution | |
| PP22-22180 | Width 9 mm | In distribution |
| PP22-22140 | Width 9 mm | In distribution |
| PP22-22130 | Height 13 mm | In distribution |
| PT22-25114 | Height 11 mm | In distribution |
| PP20-22070 | Height 7 mm | In distribution |
| PP22-28140 | Width 9 mm | In distribution |
| PT22-25094 | Length 25 mm | In distribution |
| PP20-32090 | Length 32 mm | In distribution |
| PP20-28134 | Height 13 mm | In distribution |
| PP20-22180 | Length 22 mm | In distribution |
| PP20-25120 | Length 25 mm | In distribution |
| PP20-32080 | Height 8 mm | In distribution |
| PP10-20074 | Length 20 mm | In distribution |
| PP20-28164 | Length 28 mm | In distribution |
| PP20-25160 | Length 25 mm | In distribution |
| PP22-25150 | Width 9 mm | In distribution |
| PP22-28180 | Width 9 mm | In distribution |
| PP22-28110 | Length 28 mm | In distribution |
| PP22-22150 | Height 15 mm | In distribution |
| PT22-28074 | Length 28 mm | In distribution |
| PP22-28080 | Width 9 mm | In distribution |
| PT22-28154 | Length 28 mm | In distribution |
| PT22-22154 | Length 22 mm | In distribution |
| PP22-25144 | In distribution | |
| PP22-28084 | In distribution | |
| PP22-28074 | In distribution | |
| PP20-28084 | Length 28 mm | In distribution |
| PP20-32110 | Height 11 mm | In distribution |
| PP22-25070 | Length 25 mm | In distribution |
| PP22-25104 | In distribution | |
| PP20-28180 | Height 18 mm | In distribution |
| PP22-28164 | In distribution | |
| PP20-28090 | Length 28 mm | In distribution |
| PP20-28120 | Height 12 mm | In distribution |
| PP10-20104 | Length 20 mm | In distribution |
| PP10-20094 | Height 9 mm | In distribution |
| PP10-20084 | Height 8 mm | In distribution |
| PT22-28094 | Height 9 mm | In distribution |
| PP20-25170 | Length 25 mm | In distribution |
| PP20-28140 | Length 28 mm | In distribution |
| PP22-25184 | In distribution | |
| PP22-22110 | Length 22 mm | In distribution |
| PP20-28080 | Length 28 mm | In distribution |
| PP22-22120 | Length 22 mm | In distribution |
| PP20-22080 | Height 8 mm | In distribution |
| PP20-22140 | Height 14 mm | In distribution |
| PP22-28104 | In distribution | |
| PP20-25080 | Length 25 mm | In distribution |
| PP22-28130 | Length 28 mm | In distribution |
| PP20-22170 | Height 17 mm | In distribution |
| PP20-32160 | Length 32 mm | In distribution |
| PP20-28100 | Length 28 mm | In distribution |
| PP22-28100 | Width 9 mm | In distribution |
| PT22-28174 | Length 28 mm | In distribution |
| PP20-28124 | Length 28 mm | In distribution |
| PP22-28124 | In distribution | |
| PP20-25100 | Height 10 mm | In distribution |
| PP22-22100 | Height 10 mm | In distribution |
| PP20-28150 | Height 15 mm | In distribution |
| PP22-22090 | Length 22 mm | In distribution |
| PP22-22070 | Height 7 mm | In distribution |
| PP22-25094 | In distribution | |
| PP22-25090 | Width 9 mm | In distribution |
| PP22-22160 | Height 16 mm | In distribution |
| PT22-25134 | Height 13 mm | In distribution |
| PP22-25084 | In distribution | |
| PP20-28104 | Height 10 mm | In distribution |
| PP22-25100 | Width 9 mm | In distribution |
| PT22-22094 | Height 9 mm | In distribution |
| PP22-25180 | Length 25 mm | In distribution |
| PP22-22094 | In distribution | |
| PP20-22130 | Height 13 mm | In distribution |
| PP22-25110 | Width 9 mm | In distribution |
| PP22-28070 | Height 7 mm | In distribution |
| PP20-25110 | Length 25 mm | In distribution |
| PT22-22134 | Height 13 mm | In distribution |
| PP10-20154 | Length 20 mm | In distribution |
| PP20-22100 | Length 22 mm | In distribution |
| PP22-28150 | Height 15 mm | In distribution |
| PP22-28120 | Width 9 mm | In distribution |
| PP10-20114 | Length 20 mm | In distribution |
| PP20-22120 | Length 22 mm | In distribution |
| PT22-22184 | Length 22 mm | In distribution |
| PP20-32170 | Height 17 mm | In distribution |
| PP22-22124 | In distribution | |
| PP20-22110 | Length 22 mm | In distribution |
| PP10-20134 | Height 13 mm | In distribution |
| PP20-28110 | Height 11 mm | In distribution |
| PP22-22184 | In distribution | |
| PP22-25164 | In distribution | |
| PP20-22150 | Length 22 mm | 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
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.