Silverstone Titanium Interbody Fusion System
22x10x16mm 5degree PEEK Silverstone-T
14manufacturers in China registered for this device type
292catalogue 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 | Altus Spine, United States |
|---|---|
| FDA product code | MAX |
| Device type | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| 510(k) | K171329 |
| Record published | 2017-09-01 |
| Record revised | 2020-02-24 (version 4) |
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, manufacturing date |
| Sizes | Length 22 to 32 mm; height 6 to 18 mm; width 10 mm; angle 5 to 8 ° |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ST83210T | Length 32 mm | In distribution |
| ST03215T2 | Width 10 mm | In distribution |
| ST02216T | Width 10 mm | In distribution |
| ST82214T2 | Width 10 mm | In distribution |
| ST52216 | Length 22 mm | In distribution |
| SP221014T2 | Length 22 mm | In distribution |
| ST03208T | Width 10 mm | In distribution |
| ST83207T | Width 10 mm | In distribution |
| ST03210T | Width 10 mm | In distribution |
| SP261013T2 | Length 26 mm | In distribution |
| ST52206 | Length 22 mm | In distribution |
| ST82207T | Angle 8 ° | In distribution |
| ST02808T2 | Length 28 mm | In distribution |
| SP221012T2 | Width 10 mm | In distribution |
| ST52808T2 | Angle 5 ° | In distribution |
| SP261015T2 | Height 15 mm | In distribution |
| SP301006T | Length 30 mm | In distribution |
| ST53208T | Width 10 mm | In distribution |
| ST83215T | Width 10 mm | In distribution |
| SP261014T | Width 10 mm | In distribution |
| ST83206T | Width 10 mm | In distribution |
| ST52816T | Length 28 mm | In distribution |
| SP221014T | Height 14 mm | In distribution |
| ST53215T2 | Angle 5 ° | In distribution |
| ST52809 | Width 10 mm | In distribution |
| ST82215T2 | Angle 8 ° | In distribution |
| ST02810T2 | Width 10 mm | In distribution |
| ST02213T2 | Height 13 mm | In distribution |
| ST83208T | Width 10 mm | In distribution |
| ST02214T2 | Length 22 mm | In distribution |
| SP301018T | Height 18 mm | In distribution |
| ST02206T | Height 6 mm | In distribution |
| ST82210T | Angle 8 ° | In distribution |
| ST52210T | Height 10 mm | In distribution |
| SP221010T2 | Height 10 mm | In distribution |
| ST52215 | Width 10 mm | In distribution |
| ST82212T2 | Length 22 mm | In distribution |
| ST52811T | Height 11 mm | In distribution |
| ST52812 | Height 12 mm | In distribution |
| ST02210T2 | Height 10 mm | In distribution |
| ST53215T | Height 15 mm | In distribution |
| SP301009T | Length 30 mm | In distribution |
| ST53208T2 | Angle 5 ° | In distribution |
| ST52209T2 | Height 9 mm | In distribution |
| ST52206T2 | Height 6 mm | In distribution |
| SP261007T | Length 26 mm | In distribution |
| ST52214 | Length 22 mm | In distribution |
| ST02815T2 | Length 28 mm | In distribution |
| ST83209T | Length 32 mm | In distribution |
| ST03211T | Height 11 mm | In distribution |
| ST03211T2 | Height 11 mm | In distribution |
| ST52814 | Angle 5 ° | In distribution |
| ST03214T2 | Width 10 mm | In distribution |
| ST03212T2 | Width 10 mm | In distribution |
| ST52207 | Angle 5 ° | In distribution |
| SP301008T | Width 10 mm | In distribution |
| ST02213T | Width 10 mm | In distribution |
| ST53212T2 | Angle 5 ° | In distribution |
| ST03213T | Length 32 mm | In distribution |
| ST82206T2 | Angle 8 ° | In distribution |
| ST02215T | Length 22 mm | In distribution |
| ST02811T2 | Width 10 mm | In distribution |
| ST02208T | Width 10 mm | In distribution |
| SP221010T | Length 22 mm | In distribution |
| ST52211T | Angle 5 ° | In distribution |
| ST82207T2 | Angle 8 ° | In distribution |
| ST82806T2 | Angle 8 ° | In distribution |
| SP301008T2 | Length 30 mm | In distribution |
| ST82213T | Height 13 mm | In distribution |
| ST03214T | Height 14 mm | In distribution |
| ST02214T | Height 14 mm | In distribution |
| SP221009T | Length 22 mm | In distribution |
| ST03213T2 | Width 10 mm | In distribution |
| ST02810T | Width 10 mm | In distribution |
| ST53209T | Angle 5 ° | In distribution |
| SP261010T | Length 26 mm | In distribution |
| ST52215T2 | Width 10 mm | In distribution |
| SP261008T | Width 10 mm | In distribution |
| ST82209T2 | Width 10 mm | In distribution |
| ST82216T2 | Height 16 mm | In distribution |
| ST83211T | Height 11 mm | In distribution |
| ST02812T2 | Height 12 mm | In distribution |
| ST53207T2 | Length 32 mm | In distribution |
| ST82815T | Angle 8 ° | In distribution |
| ST82210T2 | Angle 8 ° | In distribution |
| ST53209T2 | Height 9 mm | In distribution |
| ST53206T2 | Height 6 mm | In distribution |
| ST52211T2 | Angle 5 ° | In distribution |
| ST52212T2 | Height 12 mm | In distribution |
| SP221013T | Height 13 mm | In distribution |
| ST52816 | Height 16 mm | In distribution |
| ST83212T2 | Width 10 mm | In distribution |
| ST02814T2 | Width 10 mm | In distribution |
| SP221007T2 | Height 7 mm | In distribution |
| ST02207T2 | Width 10 mm | In distribution |
| ST52212T | Height 12 mm | In distribution |
| ST52816T2 | Length 28 mm | In distribution |
| ST52215T | Angle 5 ° | In distribution |
| ST02809T | Width 10 mm | In distribution |
| ST52806 | Angle 5 ° | In distribution |
| SP301015T2 | Length 30 mm | In distribution |
| SP301016T2 | Length 30 mm | In distribution |
| ST82813T2 | Angle 8 ° | In distribution |
| SP261011T2 | Height 11 mm | In distribution |
| SP261014T2 | Width 10 mm | In distribution |
| ST03216T | Length 32 mm | In distribution |
| ST82811T | Length 28 mm | In distribution |
| ST82211T2 | Height 11 mm | In distribution |
| ST83213T | Angle 8 ° | In distribution |
| ST82208T | Height 8 mm | In distribution |
| ST52814T2 | Height 14 mm | In distribution |
| ST82814T2 | Width 10 mm | In distribution |
| ST52208T2 | Angle 5 ° | In distribution |
| SP301007T | Height 7 mm | In distribution |
| ST02207T | Height 7 mm | In distribution |
| ST03210T2 | Width 10 mm | In distribution |
| SP221009T2 | Height 9 mm | In distribution |
| ST83215T2 | Length 32 mm | In distribution |
| ST02206T2 | Length 22 mm | In distribution |
| SP221008T | Angle 7 ° | In distribution |
| ST53210T | Height 10 mm | In distribution |
| SP261017T | Length 26 mm | In distribution |
| ST02809T2 | Length 28 mm | In distribution |
| ST83216T2 | Width 10 mm | In distribution |
| SP301016T | Angle 7 ° | In distribution |
| ST02815T | Width 10 mm | In distribution |
| ST52209 | Height 9 mm | In distribution |
| SP221008T2 | Height 8 mm | In distribution |
| ST02806T2 | Width 10 mm | In distribution |
| ST52207T2 | Length 22 mm | In distribution |
| ST52214T | Height 14 mm | In distribution |
| SP261016T2 | Length 26 mm | In distribution |
| SP261016T | Width 10 mm | In distribution |
| ST02816T2 | Width 10 mm | In distribution |
| SP221006T2 | Height 6 mm | In distribution |
| SP301013T | Angle 7 ° | In distribution |
| ST83209T2 | Width 10 mm | In distribution |
| ST03208T2 | Width 10 mm | In distribution |
| ST82212T | Angle 8 ° | In distribution |
| ST52808T | Angle 5 ° | In distribution |
| ST02211T2 | Height 11 mm | In distribution |
| ST02806T | Width 10 mm | In distribution |
| ST82808T | Length 28 mm | In distribution |
| SP261012T | Length 26 mm | In distribution |
| ST82211T | Length 22 mm | In distribution |
| ST52810T2 | Width 10 mm | In distribution |
| SP301014T | Length 30 mm | In distribution |
| ST02215T2 | Width 10 mm | In distribution |
| ST82812T2 | Width 10 mm | In distribution |
| SP221006T | Height 6 mm | In distribution |
| ST52809T | Height 9 mm | In distribution |
| ST03212T | Length 32 mm | In distribution |
| ST52207T | Angle 5 ° | In distribution |
| ST53214T | Height 14 mm | In distribution |
| ST82214T | Angle 8 ° | In distribution |
| ST82806T | Height 6 mm | In distribution |
| ST52216T | Height 16 mm | In distribution |
| SP301010T2 | Width 10 mm | In distribution |
| SP221017T | Height 17 mm | In distribution |
| ST53207T | Length 32 mm | In distribution |
| SP261013T | Width 10 mm | In distribution |
| SP301007T2 | Width 10 mm | In distribution |
| ST03209T2 | Length 32 mm | In distribution |
| ST52812T | Angle 5 ° | In distribution |
| ST52208T | Length 22 mm | In distribution |
| SP221016T2 | Width 10 mm | In distribution |
| ST52810T | Angle 5 ° | In distribution |
| SP221018T | Height 18 mm | In distribution |
| ST52815T2 | Height 15 mm | In distribution |
| SP301012T | Height 12 mm | In distribution |
| ST02210T | Width 10 mm | In distribution |
| ST82810T2 | Height 10 mm | In distribution |
| ST83214T2 | Angle 8 ° | In distribution |
| ST52807 | Length 28 mm | In distribution |
| SP221015T2 | Length 22 mm | In distribution |
| SP261011T | Height 11 mm | In distribution |
| ST03209T | Length 32 mm | In distribution |
| ST52815T | Height 15 mm | In distribution |
| ST02813T2 | Width 10 mm | In distribution |
| ST83210T2 | Width 10 mm | In distribution |
| ST52807T2 | Width 10 mm | In distribution |
| SP301014T2 | Height 14 mm | In distribution |
| ST82813T | Height 13 mm | In distribution |
| ST82811T2 | Width 10 mm | In distribution |
| ST53213T | Height 13 mm | In distribution |
| SP221007T | Width 10 mm | In distribution |
| SP261010T2 | Width 10 mm | In distribution |
| ST52806T2 | Angle 5 ° | In distribution |
| ST52208 | Angle 5 ° | In distribution |
| ST52815 | Length 28 mm | In distribution |
| SP301011T | Height 11 mm | In distribution |
| ST53210T2 | Width 10 mm | In distribution |
| SP221011T | Width 10 mm | In distribution |
| SP221011T2 | Width 10 mm | In distribution |
| SP261009T | Width 10 mm | In distribution |
| ST53212T | Height 12 mm | In distribution |
| SP221012T | Angle 7 ° | In distribution |
| ST82816T2 | Length 28 mm | In distribution |
| ST02812T | Width 10 mm | In distribution |
| ST52813T | Height 13 mm | In distribution |
| SP261008T2 | Width 10 mm | In distribution |
| ST03206T2 | Width 10 mm | In distribution |
| ST03216T2 | Height 16 mm | In distribution |
| ST83211T2 | Length 32 mm | In distribution |
| ST82213T2 | Angle 8 ° | In distribution |
| ST02212T | Height 12 mm | In distribution |
| ST52811T2 | Angle 5 ° | In distribution |
| ST02811T | Width 10 mm | In distribution |
| ST52811 | Length 28 mm | In distribution |
| SP261007T2 | Width 10 mm | In distribution |
| ST83213T2 | Angle 8 ° | In distribution |
| SP221016T | Height 16 mm | In distribution |
| ST82807T2 | Width 10 mm | In distribution |
| ST02208T2 | Length 22 mm | In distribution |
| ST52213T | Height 16 mm | In distribution |
| ST82808T2 | Angle 8 ° | In distribution |
| ST53216T2 | Width 10 mm | In distribution |
| ST52813 | Length 28 mm | In distribution |
| SP261009T2 | Height 9 mm | In distribution |
| ST52213T2 | Angle 5 ° | In distribution |
| SP301015T | Height 15 mm | In distribution |
| ST52813T2 | Length 28 mm | In distribution |
| SP261012T2 | Width 10 mm | In distribution |
| ST03215T | Width 10 mm | In distribution |
| ST82814T | Angle 8 ° | In distribution |
| ST03207T | Height 7 mm | In distribution |
| ST02209T | Length 22 mm | In distribution |
| ST52812T2 | Width 10 mm | In distribution |
| ST82215T | Angle 8 ° | In distribution |
| SP261015T | Height 15 mm | In distribution |
| ST52807T | Angle 5 ° | In distribution |
| ST02813T | Length 28 mm | In distribution |
| ST83206T2 | Width 10 mm | In distribution |
| ST83207T2 | Angle 8 ° | In distribution |
| SP221015T | Height 15 mm | In distribution |
| ST53214T2 | Width 10 mm | In distribution |
| ST53211T2 | Angle 5 ° | In distribution |
| SP301012T2 | Width 10 mm | In distribution |
| ST52216T2 | Angle 5 ° | In distribution |
| ST52213 | Angle 5 ° | In distribution |
| ST02816T | Width 10 mm | In distribution |
| ST52809T2 | Width 10 mm | In distribution |
| ST52806T | Length 28 mm | In distribution |
| ST82209T | Height 9 mm | In distribution |
| SP261006T2 | Height 6 mm | In distribution |
| ST53206T | Height 6 mm | In distribution |
| ST83212T | Width 10 mm | In distribution |
| ST52212 | Width 10 mm | In distribution |
| ST82216T | Length 22 mm | In distribution |
| ST83208T2 | Width 10 mm | In distribution |
Showing 250 of 292 catalogue numbers.
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.